Pain / Anesthetics

Pharmos Announces Clinical Data From Phase 2a Trial Of Cannabinor For Capsaicin-induced Pain

2007-05-07T10:06:00.001-07:00

Pharmos Corp. (Nasdaq: PARS) today announced preliminary results from its Phase 2a study evaluating intravenous (i.v.) cannabinor, a CB2-selective synthetic cannabinoid compound, in a capsaicin-induced pain model. The drug candidate did not meet the primary endpoint defined by analgesic effects compared to placebo, but confirmed safety and tolerability observed in previous studies. All subjects completed the treatment with no serious adverse events or significant cardiovascular effects.

The randomized, double-blinded, two-way crossover study enrolled 24 healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia (pain resulting from a non- noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense).

"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," said Dr. Haim Aviv, Chairman & CEO. "We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a Phase I safety trial in healthy volunteers. Based on preclinical results of oral cannabinor, its prospects as a potential treatment for neuropathic pain are promising." Pharmos recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor, the data from which support initiation of Phase 1 testing.

The Company expects to complete its separate, ongoing Phase 2a clinical trial of cannabinor as a treatment for nociceptive pain in the first quarter of 2007. The single-center, randomized, double-blinded, single-administration study compares different i.v. doses of cannabinor with placebo. The completed study will involve 100 healthy male subjects experiencing pain following third molar dental extraction.

About Cannabinor and CB2-Selective Cannabinoids

Cannabinor has demonstrated efficacy in a number of preclinical animal models of pain, inflammation and autoimmune disease. Analgesic activity has been documented in nociceptive, neuropathic, visceral and inflammatory pain in rodents and in post-operative pain in a porcine surgery model. The magnitude of analgesia was generally equivalent or greater than that of accepted comparator agents, including morphine, non-steroidal anti-inflammatory drugs and Gabapentin. In a number of models where duration of analgesia was measured, cannabinor remained effective at reducing pain significantly longer than morphine. Preliminary evidence from preclinical studies also suggests that tolerance to the therapeutic effect of cannabinor might not occur. A drug that remains effective without increasing dosage would be a valuable advance in treating severe pain.

Pharmos' cannabinoid research focus has been geared toward the development of selective and specific CB2 receptor agonists. Because they range from having little (CB2-selective) to barely detectable (CB2-specific) affinity for the central nervous system-located CB1 receptor, CB2-selective and -specific agonists lack the unwanted psychotropic side effects of many natural cannabinoids. CB2 agonists bind to CB2 receptors, which are located on immune and inflammatory cells. By activating CB2 receptors, CB2 agonists inhibit autoimmune and inflammatory processes, and are likely to be useful for treating pain, autoimmune, inflammatory and degenerative disorders. Pharmos is developing its CB2 agonists as treatments for chronic pain and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. Cannabinor is the first lead candidate to emerge from this body of Pharmos' proprietary technology.

About Pharmos Corporation

Pharmos discovers and develops novel therapeutics to treat a range of indications with a focus on specific diseases of the nervous system including disorders of the brain-gut axis (gastrointestinal/irritable bowel syndrome (IBS)), pain/inflammation, and autoimmune disorders. The Company's lead product, dextofisopam, has completed Phase 2a testing in IBS, with positive effect on the primary efficacy endpoint (n=141, p=0.033). The Company plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007. The Company's core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Cannabinor and other CB2 agonist compounds in Pharmos' pipeline are in clinical and pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders. Pharmos is also working to commercialize its unique proprietary NanoEmulsion drug delivery system, which is in clinical stage development for topical application of analgesic and anti-inflammatory agents.

Pharmos Corp.
http://www.pharmoscorp.com

Long-Term Narcotics Use For Back Pain May Be Ineffective And Lead To Abuse

2007-05-07T09:06:00.001-07:00

Narcotic drugs (opioids) are commonly prescribed for short-term relief of chronic back pain, but their effectiveness long-term has been questioned in a review article by researchers at Yale School of Medicine, who also found that behaviors consistent with opioid abuse was reported in 24 percent of cases.

"Patients with chronic back pain commonly request pain medication, and opioid medications are used despite the concerns clinicians have with patients developing an addiction to these medications," said first author Bridget Martell, M.D., assistant clinical professor of general internal medicine at Yale School of Medicine. "Our findings suggest that clinicians should consider other treatments with similar benefits but fewer long-term adverse effects."

Published in the January 16 Annals of Internal Medicine, Martell and co-authors conducted a systematic literature review and meta-analysis that addressed the prevalence and effectiveness of opioid prescriptions for patients with chronic back pain, and the incidence of substance abuse disorders among patients receiving opioid medications for chronic back pain.

The study populations consisted of non-obstetric patients over age 18 with non-malignant chronic back pain lasting for at least three months. The research focused on efficacy of oral, transdermal, or topical opioids, where there was no pre-existing diagnosis of opioid dependence. According to the report, opioids may be effective for the short-term (less than four months) treatment of chronic low back pain, but long-term effectiveness was not conclusive.

"Our results also demonstrate that the quality of the literature on these topics is generally weak and more studies need to be done before firm conclusions can be made," said Martell.

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In addition to Martell and corresponding author David Fiellin, M.D., associate professor of general internal medicine at Yale, other authors on the study included Patrick G. O'Connor, M.D., Robert D. Kerns, William C. Becker, M.D., Knashawn H. Morales and Thomas R. Kosten, M.D.

Citation: Annals of Internal Medicine, Vol. 146, No. 2 (January 16, 2007)

Yale News Releases are available via the World Wide Web at http://www.yale.edu/opa

For further information please go to:
Yale University

Childhood Obesity Linked To Foot Pain

2007-05-07T08:06:00.001-07:00

January 17, 2007) Doctors with the American College of Foot and Ankle Surgeons (ACFAS) say they're noticing more and more overweight and obese children with foot and ankle pain in their examining rooms, mirroring a national epidemic of childhood obesity.

An estimated 16 percent of U.S. children ages six to 19 are overweight. Poor diet, lack of exercise and genetics can play a role. A "vicious cycle" of foot pain and obesity traps some children.

"You want overweight children to exercise and lose weight, but because of their weight, their feet hurt and they can't exercise," says Thanh Dinh, DPM, FACFAS, a foot and ankle surgeon in Boston.

The foot is a complex structure consisting of 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. Last November, researchers in Britain reported "alarming new evidence that childhood obesity changes foot structure and results in instability when walking." Being overweight flattens the foot, straining the plantar fascia, a band of tissue which runs from the heel to the base of the toes, causing heel pain.

Because the heel bone is not fully developed until age 14 or older, overweight children are more prone to Sever's disease. Although not an actual disease, according to FootPhysicians.com, it involves an inflammation of the heel's growth plate due to muscle strain and repetitive stress. Walking makes the pain worse. Being overweight may also cause stress fractures, or hairline fractures (breaks) in a child's heel bone.

Arch pain afflicts many of the children treated by Darryl Haycock, DPM, FACFAS. The northwest Ohio foot and ankle surgeon says the average age of these boys and girls ranges from eight to 12, but he's treated some as young as four.

"The numbers are definitely increasing. I treat four to five overweight children a week," he says.

Haycock notes some overweight children suffer foot pain from congenital or inherited foot conditions, such as bunions, hammertoes, pediatric flatfoot and tarsal coalition, an abnormal connection between two or more bones in the back of the foot. Children with these deformities may be less active because of pain. Sometimes a child will complain of calf or arch pain. This results from a flatfoot that is flexible. The collapsing of the arch can require more energy, making it more difficult for a child to walk and run.

Foot and ankle surgeons treat many overweight children with custom orthotic devices (shoe inserts), physical therapy and other conservative measures to reduce or eliminate pain. But treating painful feet and ankles is only part of the childhood weight loss equation, says Samuel Nava, DPM, FACFAS. The suburban Dallas surgeon has treated weight-related foot problems in toddlers to teenagers.

"As foot and ankle surgeons, we can reduce the aches and pains so these children can run around and play like all the other kids, but parents need to watch their childrens' lifestyles and diets," he says.

For more information on pediatric foot and ankle conditions, or to find a foot and ankle surgeon, visit the ACFAS patient information Web site, http://FootPhysicians.com.

The American College of Foot and Ankle Surgeons (ACFAS) is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College's mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer website, http://www.footphysicians.com.

American College of Foot and Ankle Surgeons
8725 W. Higgins Rd., #555
Chicago, IL 60631
United States
http://www.acfas.org

Leading Radiofrequency Manufacturer Introduces A New Product For Treating Heel Pain

2007-05-07T07:06:00.001-07:00

NeuroTherm, Inc., a global leader in radiofrequency generators for chronic pain management, announces the introduction of an RF product specifically for the podiatric market: The PodiaTherm RF Generator, designed to treat chronic heel pain, which often is associated with plantar fasciitis.

Plantar fasciitis, or inflammation of the plantar fascia, is considered the most common cause of heel pain. The plantar fascia is a ligament connecting the heel bone to the toes and supporting the arch of the foot. If strained, it can develop small tears and be weakened, swollen or irritated, thus resulting in pain while walking or standing.

"As many as two million Americans are affected by plantar fasciitis each year," says William Rittman, NeuroTherm's Chief Technology Officer. "Of those, approximately 10 percent require advanced treatment because conventional therapies, such as over-the-counter medications, splints and rest, haven't alleviated the pain. That's where PodiaTherm can help."

The PodiaTherm employs radiofrequency therapy to block the pain by affecting the nerve causing the pain, Rittman says. Basically, the physician isolates the sensory nerve, which is a branch of the lateral plantar nerve, and inserts an RF electrode. The PodiaTherm then transmits a signal through the electrode, creating a lesion on the nerve in a process called thermoneurolysis.

"Once conventional therapies have been exhausted, patients have had fewer treatment options other than surgery. This will be a minimally invasive, office-based procedure," says Laurence Hicks, NeuroTherm CEO and President. Previously, advanced, non-surgical therapies either required bruising the tendons with shockwaves or making an inch-long incision to treat the tendon internally. The PodiaTherm requires only a local anesthetic and a needle's width incision. The RF therapy can be performed in a physician's office, at a hospital or in a surgery center.

"RF therapy with the PodiaTherm will become the treatment of choice for many podiatrists and patients, particularly because it's a simple, effective and safe procedure," Hicks states.

According to Rittman, radiofrequency therapy has been used successfully for many years to treat chronic pain. The RF procedure is commonly reimbursed through insurance. It also will cost less than other non-conventional therapies.

Moreover, the PodiaTherm is a small machine, so it can be transported easily from one facility to the next as the physician requires.

NeuroTherm, Inc. is a leading manufacturer of radiofrequency generators and related consumables used in the treatment of chronic pain. The company recently introduced the NT1000, the world's first RF generator capable of producing three lesions simultaneously. NeuroTherm also pioneered the development and use of disposable electrodes in the U.K. market.

NeuroTherm is based in Middleton, MA., with another facility outside London, England. The company was formed in September 2005, as a concurrent acquisition of RDG Medical in the U.K., and RF Medical and Precision Medical Engineering in the U.S. by Cortec Group Fund III, L.P., an affiliate of Cortec Group, Inc. Additional information about NeuroTherm can be found on the Internet at http://www.neurotherm.com.

Additional information about the PodiaTherm RF Generator can be found on the Internet at http://www.podiatherm.com.

NeuroTherm, Inc.
http://www.neurotherm.com

Consumers Should Talk To Their Pharmacists About Pain Reliever Safety Pharmacists Can Answers Questions If Consumers Have Concerns

2007-04-16T17:13:00.001-07:00

Each year, millions of consumers use pain relievers to treat everything from back aches to symptoms associated with the common cold. Some estimates place the number as high as 48 million in a given week. But as with all medications, products containing acetaminophen, aspirin or ibuprofen should be used with care. Exceeding the recommended daily dose can jeopardize the consumer's recovery and pose real health problems. Recently, the Food and Drug Administration (FDA) has proposed that the most popular pain relievers carry additional warnings on their labels that overuse may result in stomach bleeding or liver and kidney damage.

"It is important for consumers to remember that products containing acetaminophen and some of these other nonsteroidal anti-inflammatory drugs are safe and effective when used properly," said Past APhA President Dr. Jan Engle. "Pharmacists and other healthcare providers always emphasize to patients that they should know the ingredients in all of their medications, including those they buy over the counter. If a patient is concerned that they might be overmedicating, they should speak with their doctor or pharmacist immediately."

APhA recommends the following for consumers who may be taking a pain reliever regularly:

-- Read the label, Follow the Directions -- Consumers should always know which active ingredients are in the products they are using and follow the recommended dose. Do not exceed the recommended daily dose and do not take the medication for longer than directed.

-- Know Your Medicine, Talk to Your Healthcare Provider -- You should not only know the name of your medication, but the common ingredients as well. A consumer survey commissioned by APhA last year confirmed that only 55% of consumer knew the active ingredients of their prescription medicine. Consumers need to 'know their medicine' - many of the most common prescription and over the counter pain relievers and cold treatments contain similar ingredients, which could result in overmedication. If consumers have questions, they should talk to their pharmacist or doctor.

-- Over the counter pain relievers are safe when used as directed on the label -- When used as directed, over the counter pain relievers are safe. People should not stop taking prescribed pain relievers without first consulting their physician.

-- Talk to your pharmacist about over the counter pain medications. Your pharmacist can help you choose the best product for your condition.

The American Pharmacists Association is dedicated to improving medication use and advancing patient care. Founded in 1852 as the American Pharmaceutical Association, APhA is the first established and largest professional association of pharmacists in the United States. APhA's more than 57,000 members include pharmacists, scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession.

American Pharmacists Association
http://www.aphanet.com/

Chiropractic Resolutions For A Healthy, Pain-Free Year

2007-04-16T16:33:00.001-07:00

Start the new year off right by committing to a healthier lifestyle. A few simple and practical lifestyle changes can make a positive impact on your health and can also prevent you from experiencing a painful injury in the year ahead, according to the American Chiropractic Association (ACA).

The ACA and your local doctor of chiropractic urge you to adopt the following New Year's resolutions for a healthier 2007.

1) I will limit my intake of caffeinated coffee, sodas and teas. The caffeine in these drinks can cause dehydration and can rob the body of essential nutrients. Stick to water, natural juices and other decaffeinated beverages.

2) I will avoid over medicating myself and my family. Many over-the- counter and prescription medications have unknown side effects. Discuss alternative remedies with a doctor of chiropractic.

3) I will not carry a heavy purse or briefcase with its strap over my shoulder, unless I place the strap over my head on the side opposite the bag. Wearing a shoulder strap over one shoulder unevenly places the weight of the bag on one side of the body, potentially causing shoulder and back pain.

4) I will not allow my children to carry backpacks that weigh more than 10 percent of their body weight. Beyond that weight, the backpack can cause the wearer to bend forward in an attempt to support the weight on his or her back, instead of the shoulders.

5) I will not lift heavy objects over my head. These types of movements can strain muscles and affect nerves, causing severe neck, shoulder and arm problems.

6) I will not turn my torso while lifting relatively heavy objects. This rotates the spine and can bring on a "back attack."

7) I will avoid the habit of consistently crossing the same knee over the other. Such a habit can also eventually cause misalignment of the spine.

8) I will try to keep moving while I'm at work. If sedentary for the majority of the work day, it is very important to take periodic stretch breaks. Get up from the desk and take a brief walk, and stretch arms and legs as frequently as possible to avoid postural and spinal stress.

9) I will, when using a shovel - in winter or summer - remember to push rather than lift, whenever possible.

10) I will use luggage with wheels whenever possible. Carrying, lifting and moving a heavy suitcase can ruin a vacation.

For more information on chiropractic care, or to find a chiropractor near you, visit ACA's Web site at: http://www.acatoday.org.

American Chiropractic Association
http://www.acatoday.com/

'Botox' Can Ease Writer's Cramp

2007-04-16T15:12:00.000-07:00

Botox"' the popular anti- wrinkle treatment, can also ease writer's cramp, suggests a small study published ahead of print in the Journal of Neurology Neurosurgery and Psychiatry.

Writer's cramp describes the painful involuntary, spasmodic muscle contractions of the fingers, hand, or arm during writing. But it can also occur during other manual tasks.

Some people learn to write with their other hand, but in one in four cases, the condition affects both hands, and the condition is difficult to treat. It affects around three to seven in every 100,000 people.

Relaxation techniques, hypnosis, biofeedback, acupuncture, and 'writing re-education exercises' have all been used, but none of these brings sustained relief. And there is as yet no effective drug treatment.

Forty people with writer's cramp were randomly assigned to a course of injections containing either botulinum toxin (botox) or a dummy substitute in two doses, usually into two muscles, over a period of 12 weeks.

Of the 20 people given botox treatment, 14 (70%) said that their condition had significantly improved, and that they wished to continue treatment. Their improvement was confirmed using validated disability and pain scales.

Only six of the 19 people in the dummy group felt that their condition had improved. One person dropped out of the trial.

One person who received the dummy injection at the first session and botox at the second, also registered an improvement in symptoms.

After a year, half of the trial participants were still receiving botox injections, and were finding them helpful.

Side effects included mild and temporary muscle weakness and pain at the injection site. Symptom relief lasted from three to 18 months, with an average symptom free period of four and a half months.

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Contact: Emma Dickinson
BMJ Specialty Journals

Workers' Compensation Ratings Don't Accurately Predict Disabilities

2007-04-16T14:33:00.001-07:00

A study of settlement decisions in workers' compensation claims for low back pain has found almost no relationship between the rating of the disability's severity when the claim was settlement and reported pain and disability 21 months later.

Findings were counterintuitive: Claimants with higher disability ratings, which suggest higher severity and less ability to work, fared better than those with lower ratings.

The study shows that "administrative decisions made at the end of the workers' compensation claim process about the ability of someone to work after back injury has very little predictive validity," said Dr. Norton Hadler, a professor of medicine and microbiology/immunology in the University of North Carolina at Chapel Hill's School of Medicine.

Hadler is a co-author of the paper, which was published in the December issue of the Journal of Pain, with colleagues from St. Louis University and the University of Florida. It was based on administrative records in Missouri of workers' compensation claims for low back pain.

Workers' compensation is an important part of America's health-care system, accounting for 3 percent of an employer's gross income, Hadler said.

"Clearly, the rating schemes for workers' compensation are inconsistent, and that fact is stirring enormous pots across the country," Hadler said. "If the outcomes from Missouri generalize, then there is a need to reform how disability is determined."

Another paradoxical finding showed that white claimants faired no better than blacks, even though previous reviews found that blacks were much less likely than whites to be diagnosed with a herniated disk or to have back surgery, had less money spent on their care and received lower disability ratings and smaller settlements.

"It's one of the more perverse observations in our study," said Hadler. "African-Americans were much less likely to be operated on, but the care that the whites got, even though it looks like more care, because it's surgery and it's more expensive, didn't do anything for them."

For their study, the researchers interviewed 580 black and 892 white workers' compensation claimants an average of 21 months after claim settlement to assess how well they were functioning and to determine the contribution of impairment, race and socioeconomic status to their disability ratings.

Hadler said that workers' compensation claims for low back pain represent only 20 to 30 percent of all claims filed but consume a majority of the workers' compensation budget.

The article concludes that "the pattern of results suggests that race/ethnicity and other sociodemographic factors influence medical decision making and вЂ¦ the outcomes of medical care." Furthermore, the flaws in the system "are not distributed evenly" but "are visited disproportionately" on minorities and persons of lower socioeconomic status.

Study collaborators were Drs. John T. Chibnall and Raymond C. Tait from Saint Louis University School of Medicine and Dr. Elena M. Andresen of the University of Florida. Tait was the study's principal investigator and lead author of the article. It is the fifth article that the quartet have published over the last two years.

University of North Carolina at Chapel Hill
210 Pittsboro St. Campus Box 6210
Chapel Hill, NC 27514
United States
http://www.unc.edu/

December Nursing News And Research Briefs

2007-04-16T13:07:00.001-07:00

High Risk Patients Use Both Conventional Medicine and Alternative Therapies for Asthma; Some Alternatives Pose Risk In depth interviews with a group of low income mostly female African Americans, all of whom had severe asthma, revealed that all participants used some form of complementary and alternative medicine (CAM) in combination with conventional medicine. Writing in this monthвЂ™s issue of the Journal of General Internal Medicine, Johns Hopkins University School Nursing researcher Maureen George, PhD, RN notes that "While most subjects trusted prescription asthma medicine, there was a preference for integration of CAM with conventional asthma treatment. CAM was considered natural, effective and potentially curative."

Among the reasons CAM was chosen as an addition to or substitute for conventional care were beliefs that treatment was "more natural" than manufactured agents; could reduce the need for conventional pharmacologic treatment such as steroids; provided protection from illness or for relief of systems; and offered some hope of a cure. While participants denied substituting CAM for prescription medication, most (63%) also reported they had not adhered to their conventional therapy in the two weeks prior to the interviews or that they had missed doses, some as many as ten or more.

The researchers also found that many participants did not disclose their CAM use to providers. When CAM therapies were preferred but covertly used, patients could be at increased risk for poor clinical outcomes due to drug-CAM interactions; unnecessary delays in seeking appropriate medical attention; and insufficient adherence to the patientвЂ™s medical plan leading to an unnecessary intensification of conventional therapies. George and colleagues also determined that some patients were using herbs and over-the-counter products in ways that could be harmful, including ingesting camphor-based or mentholated topical salves, dissolving cough lozenges as many as ten at a time in herbal tea, and taking Echinacea, an herb that could result in a worsening of asthma due to allergic reactions.

Studies Contribute to Better Understanding Pain, Reducing its Physical, Economic Consequences--Faculty member Fannie Gaston-Johansson, PhD, RN has, in collaboration with researchers at Goteborg University, Sweden, recently published two articles in BMC Nursing focusing on better understanding and managing pain.

In "Pain, psychological distress and health-related quality of life at baseline and three months after radical prostatectomy," Gaston-Johansson, notes that inadequate management of postoperative pain is common and is a risk factor for prolonged pain after surgery. In addition to medical and technical factors, psychological factors may also influence the experience of postoperative pain. The study found that patients who experienced the highest postoperative pain levels also had the longest hospital stay.

A second study examined unexplained chest pain (UCP), an increasing phenomenon often seen in Emergency Departments. In the article "Coping strategies, stress, physical activity and sleep in patients with unexplained chest pain" Dr. Gaston Johansson, examines coping strategies in patients with UCP and examines the relationships between these strategies, negative events, sleep problems, physical activity, stress and pain intensity.

In Other Nursing News:

David A. Thompson, DNSc, RN, and others published an article "Clinical and Economic Outcomes of Post-Operative Hospital Acquired Pneumonia in Patients who Receive Invasive Diagnostic Testing, and Ventilation" in the December issue of the "Journal of Clinical Outcomes Management." The article examines the clinical and economic impact of traditional technologies used in the diagnosis and management of intra-abdominal postoperative surgical patients who develop hospital acquired-pneumonia.

JHUSON doctoral student and clinical instructor Jason Farley MSN, MPH, CRNP, spent Thanksgiving in Namibia, Africa, working with the University of Namibia School of Nursing to complete a needs assessment for the 2007 implementation of a World Health Organization program вЂњIntegrated Management of Adolescent and Adult Illnesses.вЂќ The program supports a larger role for nursing personnel in developing countries in the care of persons living with HIV/AIDS.

Four JHUSON faculty members and doctoral students presented a variety of posters at the 134th Annual Meeting of the American Public Health Association (APHA) held in Boston, MA last month:

Rosemarie Brager, PhD, CRNP, presented "вЂGuided CareвЂ™ for Multi-Morbid Adults," a model that infuses contemporary primary care with state-of-the-art information technology to help address the health care of multi-morbid older Americans in an often fragmented system lacking in quality and efficiency.

Joan Kub, PhD, APRN and SON students Jessica Williams Roberts, Sarah Joyce, Nina Fredland, and Colleen Thornton delivered posters focused on the increasingly recognized public health issue of bullying in the nationвЂ™s schools: "Bullying Victimization and Associated Health Outcomes in Elementary School Students," and "No Room for Bullying, an Intervention at a Local School."

Jodi Shaefer,PhD, RN presented вЂњFetal and Infant Mortality Review (FIMR): Promoting Culturally and Linguistically Competent Health Messages in Multi-Cultural Communities,вЂќ and research conducted by Robin Newhouse, PhD, RN, вЂњDeveloping a Measure of the Impact of Legislation and Organizational Forces on Rural Hospital Nursing.вЂќ

The Johns Hopkins University School of Nursing is a global leader in nursing research, education and scholarship and is ranked among the top 10 nursing higher education institutions in the country. The SchoolвЂ™s community health program is second in the nation and the nursing research program now holds eighth position among the top nursing schools for securing federal research grants. The School continues to maintain its reputation for excellence and educates nurses who set the highest standards for patient care, exemplify scholarship, and become innovative national and international leaders in the evolution of the nursing profession and the health care system. For more information, visit http://www.son.jhmi.edu/.

Johns Hopkins University School of Nursing
525 North Wolfe St, Rm 525
Baltimore, MD 21205
United States
http://www.son.jhmi.edu/

DURECT Corporation Announces Positive Phase I Study Results With New Product In Development

2007-04-16T12:27:00.001-07:00

DURECT Corporation (Nasdaq: DRRX) announced today that it has successfully completed Phase I clinical trials with a new product, DUR-843, which is intended to treat a persistent pain condition. We believe that the persistent pain market remains underserved and that DUR-843 has the potential to provide several advantages over existing pain medications.

"We are pleased to add another product candidate to our pipeline and with the rapid progress and positive results thus far," stated James E. Brown, DVM, President and CEO of DURECT. "As a result of our recent collaboration with Nycomed covering POSIDUR, we are in a stronger financial position and therefore have decided to further develop this product on our own as part of our strategy to become a specialty pharmaceutical company. To that objective, for competitive reasons, DURECT is not disclosing at this time the specific drug delivery technology which underlies DUR-843 as well as the active pharmaceutical agent."

The objectives of the Phase I clinical studies recently completed were to determine the safety and tolerability of DUR-843 in healthy human volunteers as well as evaluate the pharmacokinetics of the active pharmaceutical agent following administration of the product candidate. In these trials, DUR-843 appeared safe and well-tolerated.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com.

DUR-843 is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT's product candidate DUR-843, its attributes and commercial potential are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 3, 2006 under the heading "Risk Factors."

DURECT Corporation
http://www.durect.com

Pain Therapeutics Initiates Phase III Study With Oxytrex(TM)

2007-04-16T11:25:00.001-07:00

Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced the initiation of a Phase III study with Oxytrex, an investigational drug. Oxytrex is a unique oral painkiller for patients who suffer from persistent severe chronic pain. The Company believes Oxytrex offers less physical dependence/withdrawal than oxycodone, an 80-year-old prescription painkiller still widely used today to treat persistent severe chronic pain.

"We remain encouraged by the strong science around Oxytrex published in several top journals, including a recent article in Journal of Neurobiology that further elucidates the unique attributes of ultra-low-dose opioid antagonists," said Remi Barbier, president and chief executive officer.

This study is being referred to as the "Extreme Study" in deference to patients who depend on extremely high daily doses of oxycodone (greater than or equal to 120 mg per day) to treat severe chronic pain. The Company believes this sub-population of patients is prone to physical dependence/withdrawal.

In the second half of 2007, Pain Therapeutics plans to initiate a large study with Oxytrex in a broad patient population.

"Extreme Study" Design

This clinical study is randomized, double-blinded, multi-center and placebo-controlled. The study will enroll approximately 120 patients who have each been taking greater than or equal to 120 mg of oxycodone per patient per day for over a year. Patients who meet this and all other eligibility requirements are randomized to receive twice-daily doses of 100 nanograms (i.e., 0.0001 mg) ultra-low-dose naltrexone or matching placebo for two weeks. At the conclusion of the treatment period, patients check into a clinic and receive an injection of a high-dose opioid antagonist to precipitate withdrawal. During the withdrawal phase of the study, patients are closely monitored and measured for signs and symptoms of physical dependence/withdrawal using the Subjective Opiate Withdrawal Scale. The study's primary endpoint is prospectively defined as physical dependence/withdrawal scores in the treated arm compared to placebo. For ethical and other reasons, the study protocol allows an interim analysis.

About Oxytrex

Pain Therapeutics owns commercial rights to Oxytrex, a unique oral painkiller that preferentially inhibits an excitatory effect of opioid receptors. This excitatory effect is believed to counteract analgesia (pain relief) and cause tolerance. Its inhibition enhances pain relief and minimizes opioid tolerance. The FDA has not yet evaluated the merits, safety or efficacy of Oxytrex.

About Pain Therapeutics, Inc.

Pain Therapeutics is a biopharmaceutical company that develops novel drugs for pain management and oncology. We have three investigational drug candidates in clinical programs. Remoxy(TM) and PTI-202 are proprietary, abuse-resistant forms of opioid drugs. Oxytrex is a novel, next-generation painkiller that potentially offers less physical dependence than currently marketed opioid painkillers. We are also developing a novel radio-labeled monoclonal antibody to treat metastatic melanoma, a rare but deadly form of skin cancer. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please consult our website: http://www.paintrials.com/.

Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.

Pain Therapeutics, Inc.
http://www.paintrials.com/

Sea Snail Key To Future Of Pain Relief

2007-04-16T11:12:00.001-07:00

Unique research at The University of Queensland could revolutionise the treatment of pain relief - thanks to a humble sea snail.

Dr Jenny Ekberg, a Research Fellow with UQ's School of Biomedical Sciences, has studied a toxin produced by a marine snail found on the Great Barrier Reef, which has the ability to precisely target chronic pain without severe side-effects.

"Chronic pain can be caused by an initial injury that affects the nerves, or conditions such as diabetes and arthritis," Dr Ekberg said.

"The problem with current drugs, such as morphine, is that they sometimes offer only marginal relief and come coupled with lots of problems with tolerance and side-effects.

"Our research show that a natural product, a conotoxin from the marine snail Conus marmoreus, produces pain relief without apparent side-effects in animal models of chronic pain."

The study, done with colleagues Professor David Adams in the School of Biomedical Sciences, Dr Richard Lewis at UQ's Institute for Molecular Bioscience and Professor Mac Christie at the University of Sydney, was recently published in the Proceedings of the National Academy of Sciences.

Dr Ekberg said with approximately one in five Australians will suffer from chronic pain at some point in their life the potential benefit of this research could be enormous.

She said sufferers of chronic pain can have the added problem of being diagnosed with no reason for the pain.

"The patient experiences severe pain because their nerve cells that are responsible for pain transmission are overactive," she said.

"This is primarily due to abnormal activity of voltage-gated sodium channels in the nerve cells.

"Conventional drugs, such as local anaesthetics, block all types of sodium channels, causing severe side-effects.

"Our toxin only blocks a specific channel - the first time a toxin like this has been shown to work - therefore providing pain relief without severe side-effects."

Dr Ekberg said it would be a number of years before such a treatment would be commercially available.

Originally from Sweden, Dr Ekberg came to UQ to complete her Honours in Biomedical Sciences and stayed to complete a PhD, from which this research stemmed, under the supervision of Professor David Adams and Associate Professor Phil Poronnik.

Dr Ekberg said she has since remained at UQ because of a combination of high-class research and a wonderful environment.

For further information please go to:
The University of Queensland, Brisbane Australia
Source:
UQ News Online

Gene Mutation Which Prevents Carriers From Feeling Pain Discovered By Cambridge Led Team

2007-04-16T10:34:00.001-07:00

Researchers have discovered a gene mutation which prevents the otherwise healthy carriers from sensing pain, after studying three related families with a rare genetic disorder in northern Pakistan.

The research, published in the journal Nature, provides insight into the mechanics of pain and could lead to the development of more effective pain treatments.

The carriers of the very rare genetic mutation are unable to perceive any form of pain but have otherwise completely normal sensory functions. The initial case study was a ten-year-old street performer in Pakistan with the genetic mutation. His inability to feel pain enabled him to place knives through his arms and walk on burning coals. (The young boy died before his fourteenth birthday from injures sustained after jumping off a roof.)

The scientists subsequently studied six individuals with the genetic mutation from three related families, all originating from northern Pakistan. The six relatives had not experienced pain at any time in their lives. Detailed neurological examinations revealed that there was no evidence of motor or sensory disease, and that they could perceive a number of sensations (including touch, warm and cold temperature, tickle and pressure).

As pain is a survival mechanism which enables organisms to minimise damage to tissues, they had all sustained a variety of injuries, including injuries to their lips and/or tongue from biting themselves when young.

By studying these individuals, the scientists were able to determine that a mutation in the gene SCN9A causes a loss of function in the voltage-gated sodium channel it encodes (subunit Nav1.7). Sodium channels are proteins which excite neurons, and though the precise function of Nav1.7 is unclear, as part of a sodium channel it would play a role in exciting sensory neurons.

Dr Geoffrey Woods, from the Department of Medical Genetics and the University of Cambridge Institute for Medical Research (CIMR), said, вЂњThis paper shows that rare diseases can still be of great importance, because of the insights they give into biological and developmental processes".

Dr John Wood, from University College London, said, вЂњThe work of Geoff Woods and his team has provided us with an exciting new target for pain killing drugs - potentially this is as important as the identification of the morphine receptors. It is fascinating that this same gene, when mutated to encode a hyperactive channel, has also been found to contribute to ongoing pain in some heritable human disordersвЂќ.

As individuals with mutations in the gene SCN9A are otherwise healthy, the scientists are hopeful that the development of drugs that prevent Nav1.7 from functioning could be used as new and potentially safer pain medications.

###

The collaborative study, spearheaded by academics at the University of Cambridge, included researchers from a number of Pakistani and UK institutions (including University College London) and was funded in part by the Wellcome Trust.

Contact: Genevieve Maul
University of Cambridge

Genetic Mechanism Helps Explain Chronic Pain Disorders

2007-04-16T10:19:00.001-07:00

Researchers at the University of North Carolina at Chapel Hill have discovered that commonly occurring variations of a gene trigger a domino effect in chronic pain disorders. The finding might lead to more effective treatments for temporomandibular joint disorder (TMJD) and other chronic pain conditions.

Catechol-O-methyltransferase (COMT), an enzyme that metabolizes neurotransmitters such as epinephrine, norepinephrine and dopamine and that has been implicated in the modulation of persistent pain, as well as cognition and mood, is regulated by a gene, also called COMT. Previous UNC-led research showed that common genetic variants of this gene are associated with increased pain sensitivity and the likelihood of developing TMJD.

Now, the researchers have discovered that specific variants of the COMT gene can dramatically affect the secondary structure of corresponding messenger RNA - which, in turn, leads to alterations in the amount of enzyme crucial for regulating pain processing. The discovery is published in the Dec. 22 issue of Science.

"TMJD is a complex pain condition that is frequently associated with other pain conditions such as fibromyalgia syndrome, chronic headaches and irritable bowel syndrome," said Dr. William Maixner, director of the Center for Neurosensory Disorders in UNC's School of Dentistry and a study co-author.

"This study has identified a new genetic mechanism that influences an individual's susceptibility to develop chronic pain conditions such as TMJD," Maixner said.

The study was conducted to understand the mechanism by which the identified genetic variants influence enzymatic activity and, ultimately, biological functions such as pain transmission. The researchers found that three major variants of COMT show significant differences in how they code for the secondary structure of messenger RNA, or mRNA. The differences lead to dramatic alterations in protein expression, which substantially influences pain sensitivity in humans.

These findings are clinically important because pain conditions resulting from low COMT activity or elevated catecholamine levels are likely to be susceptible to treatment with pharmacological agents that block beta 2- and beta 3-adrenergic receptors, which mediate COMT-dependent pain signaling, or that control mRNA secondary structure.

"Elucidating the genetic mechanisms that mediate pain perception will provide new insights into how chronic pain develops and will ultimately contribute to the identification of unique markers for diagnosing clinical pain conditions, as well as provide novel targets for the development of effective individualized therapeutics for TMJD and related conditions," said Dr. Andrea Nackley Neely, a research assistant professor in the Center for Neurosensory Disorders and the study's lead author.

"These data have broad medical and evolutionary implications regarding the analysis of variants common in the human population," Nackley Neely said. "It is believed that variants leading to altered protein structure have the strongest impact on gene function. However, this study demonstrates that combinations of common genetic variants that influence mRNA secondary structure may have even stronger effects and, thus, represent another key factor responsible for disease onset and progression."

"This study provides additional evidence of a genetic, molecular and physiological basis for pain perception and human pain conditions and should help to remove the stigma associated with conditions such as TMJD and fibromyalgia," said Dr. Luda Diatchenko, an associate professor in the center and the study's chief investigator.

Other researchers were Dr. Inna Tchivileva, a postdoctoral research associate within the Center for Neurosensory Disorders; Kathryn Satterfield, a former research assistant within the center; Dr. Olex Korchynskyi, a former postdoctoral research associate within the UNC-Chapel Hill School of Medicine's Thurston Arthritis Research Center; Dr. Sergei S. Makarov, a former associate professor at the Center for Neurosensory Disorders and the Thurston center and now president and chief executive officer of Attagene Inc.; and Dr. Svetlana A. Shabalina, a staff scientist with the National Center for Biotechnology Information.

Funding was provided by the National Institute of Dental and Craniofacial Research, National Institute of Child Health and Human Development and National Institute of Neurological Disorders and Stroke, all components of the National Institutes of Health. Additional support came from the Intramural Research Program of the National Center for Biotechnology Information.

Other Center for Neurosensory Disorders research initiatives are currently under way that further explore the genetic basis of pain: One seven-study, a $19-million National Institute of Dental and Craniofacial Research-funded agreement involving multiple institutions and based at the center, will follow 3,200 health individuals and 200 who have facial pain. Titled OPPERA (Orofacial Pain: Prospective Evaluation and Risk Assessment), the study is designed to identify both environmental and genetic factors that increase an individual's susceptibility to TMJD and other chronic pain conditions.

University of North Carolina at Chapel Hill
210 Pittsboro St. Campus Box 6210
Chapel Hill, NC 27514
United States
http://www.unc.edu/

Psychological Treatments Improve Outcomes For Back Pain Sufferers

2007-04-16T09:24:00.001-07:00

Psychological interventions for chronic low back pain are effective, a new review of studies has found. Not only do these approaches improve psychological outcomes such as depression and health-related quality of life, they also reduce patientsвЂ™ experience of pain.

вЂњBecause this analysis was both more inclusive and more conservative than previous reviews, we have the best evidence to date that these interventions are helpful,вЂќ said psychologist and review lead author Robert Kerns, Ph.D., of the VA Connecticut Healthcare System.

The review, part of a new article series, appears in the January issue of the journal Health Psychology. Each evidence-based review centers on a specific psychological assessment or treatment conducted in the context of a physical disease process or risk reduction effort.

To evaluate the effects of psychological interventions on pain-related outcomes, Kerns and his team gathered data from 22 randomized trials published between 1982 and 2003. Trials were limited to adults with nonmalignant low back pain that had persisted for at least three months. However, most patients had been living with pain for much longer. The average duration was seven and a half years.

The studies were not limited to any one psychological approach. Included in the review were behavioral and cognitive-behavioral techniques; self-regulatory techniques such as hypnosis, biofeedback, and relaxation; and supportive counseling.

The review reports on 12 pain-related outcomes, including pain intensity, pain interference, depression, health care use, disability and health-related quality of life.

In the broadest analysis, psychological interventions alone or as part of a multidisciplinary approach proved to be superior to waiting lists or standard treatments on the entire range of pain-related outcomes.

When the researchers analyzed specific outcomes, they found that the largest and most consistent effect was a reduction in pain intensity.

This was somewhat surprising, Kerns said, because when psychologists first began developing interventions for chronic pain several decades ago, the goal was not to reduce pain but to help patients live with their pain more successfully.

вЂњHowever, a growing body of knowledge suggests that these interventions are actually having a primary effect on peopleвЂ™s experience of pain,вЂќ he said.

The review found that psychological interventions also yielded improvements in health-related quality of life, work-related disability, interference of pain with daily living and depression.

Not all treatments were equally effective. Cognitive-behavioral and self-regulatory treatments seemed to yield the greatest effects, particularly when compared to waiting list control groups. Multidisciplinary approaches that included a psychological component also stood out on some measures, reducing pain interference and work-related disability when compared to other active treatments.

According to Dennis Turk, Ph.D., a professor of anesthesiology and pain research at the University of Washington in Seattle, patients with chronic pain sometimes fail to recognize the value of psychological treatments because theyвЂ™ve been set up to expect a cure.

вЂњEven the latest and greatest treatments donвЂ™t cure people with chronic pain,вЂќ he said. вЂњPsychological interventions are not cures, but they do reduce pain and improve function and they are important components in the treatment of people with chronic pain.вЂќ

Turk added that psychological interventions are also cost-effective when compared to other treatments for chronic low back pain a key finding, considering that estimates for treatment-related costs range from $20 billion to $80 billion a year in the United States.

вЂњSurgery, opioids, nerve blocks, spinal cord stimulators, implantable drug delivery systems every one of those particular alternatives is much more expensive and has poorer or at best equal outcomes compared to rehabilitation programs that include psychological components,вЂќ said Turk. вЂњThe paradox is that, despite data on the effectiveness of psychological interventions, insurers are less willing to pay for them.вЂќ

Getting the word out that these treatments are effective and cost-effective is a challenge that psychologists will have to tackle head-on, Kerns said.

вЂњWe need to specifically target health care system administrators and third-party payers to try to engage them in a more productive dialogue about the importance of these interventions,вЂќ he said. вЂњWe continue to have a huge, very costly problem in our society, but we have an intervention that is effective, and we need to do a better job of creating access to these services.вЂќ

вЂњEvidence-based Treatment ReviewsвЂќ is a new series initiated within Health Psychology, an official journal of the American Psychological Association. This series of articles is intended to inform health psychology practice, add to teaching and mentoring resources, and inspire further evidence-based research and questions.

Hoffman BM, et al. Meta-analysis of psychological interventions for chronic low back pain. Health Psychology 26 (1), 2007.

Health Behavior News Service
Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States
http://www.hbns.org

Premature Babies Probably Feel And Are Aware Of Pain

2007-04-16T09:12:00.001-07:00

Although it is wellknown that premature babies react to pain, it has not been known to what extent they are aware of pain and uncomfortable procedures. Therefore premature infants have not always received sufficient analgesia. Now, however, the grounds for this have been seriously undermined by a new doctoral thesis from Karolinska Institutet (KI) in Sweden. New measurement techniques show that even premature babies display all the signs of a conscious experience of pain.

For many years, doctors have assumed that foetuses, premature babies and fully developed new-born babies do not have the cerebral cortical functions required to feel pain. BabiesвЂ™ reactions to potentially painful stimuli have been explained away as unconscious reflexes, and so doctors have felt it justified to withhold painkillers during surgery and the like so as to avoid adverse reactions.

The doctoral thesis by Italian-Swedish researcher Marco Bartocci now shows that the brains of premature babies are far more developed than previously thought. His studies using infrared spectroscopy, carried out at the Astrid Lindgren ChildrenвЂ™s Hospital in Stockholm, Sweden, show that pain signals from a pin prick are processed in the cerebral cortex of premature babies in the same way as in adults. This means that all known pre-conditions for the conscience experience of pain are present, even though this still does not provide any conclusive evidence that they actually undergo a subjective painful experience.

The results of the processing of painful stimuli have been published in the scientific journal Pain and have been cited in a news article in Nature. They are expected to have a major impact on pain-relief management for new-born babies as well as on approaches to child development in general. Public defence of doctoral thesis will be held on December 8. Professor Michael Wweindling from the University of Liverpool, UK is the external examiner.

Thesis: Brain functional near infrared spectroscopy in human infants: cerebral cortical haemodynamics coupled to neuronal activation in response to sensory stimulation , Department of Women and Child Health, Karolinska Institutet.

Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.

http://diss.kib.ki.se/2006/91-7357-034-6

A Protein Essential For Touch Sensation - First Evidence For A Touch Receptor Gene In Mammals

2007-04-16T08:19:00.001-07:00

The skin is the largest sensory organ in humans. The sensory innervation of the skin allows us to perceive touch and pain. Now, Christiane Wetzel, a researcher in the laboratory of Professor Gary Lewin at the Max DelbrГјck Center for Molecular Medicine (MDC) Berlin-Buch, Germany, and her colleagues have deciphered the function of a molecule necessary for the conversion of mechanical stimuli into neural impulses. They have demonstrated that this molecule, a protein called SLP3, is essential for the detection and discrimination of fine tactile stimuli. This study provides the first evidence for a touch receptor gene in mammals and shows that molecules may in the future prove to be important therapeutic targets for the control of chronic pain. The findings of Christiane Wetzel and Professor Lewin were published in Nature online (DOI: 10.1038/nature05394).

Christiane Wetzel could show that mice lacking SLP3 are unable to distinguish normally between finely structured surfaces. This serious sensory deficit could be traced to the fact that around one third of the mechanoreceptors in the skin of SLP3 mutant mice fail to respond to any mechanical stimulation.

Although the sensation of touch is not usually associated with pain this situation is dramatically altered after injury to nerve. Thus many people with such injuries suffer from chronic pain in which even light brush stimuli can provoke intense pain.

This type of pain, called neuropathic pain, can be modelled in animals and mice lacking SLP3 show virtually no touch-evoked pain when confronted with such a lesion. This data further indicates that by targeting molecules involved in the detection of touch one could achieve a novel way to control neuropathic pain a clinical condition for which few effective treatment options are available.

Touch and pain are detected by sensory neurons which are located in the dorsal root ganglia (DRG) and their вЂњworking endвЂќ is in the skin attached to the cell body by a long process called the axon. Mechanical stimuli of the skin (brush or pressure) activates the вЂњworking endвЂќ of the sensory receptor and initiates an electrical signal that is relayed to the spinal cord and brain.

The sensory receptor must then convert a mechanical signal into an electrical signal and this process is called sensory mechanotransduction. It is this process of sensory mechanotransduction, that is very poorly understood in mammals. It is thought that mechanical stimuli are converted into electrical events by specialized ion channels, these channels can be opened when the membrane is physically indented, leading to an increased flow of charged ions into the cell to produce an electrical signal.

In this study the activity of such ion channels was measured in response to extremely small indentation stimuli (nanometer range). It was found that in many sensory neurons SLP3 was required for the function of such mechanosensitive channels.

This study is the very first to show any protein that is directly involved in the detection of touch in mammals. Many genes have been shown to be necessary for mechanosensation in simpler organisms like worms and flies. The SLP3 protein is also very closely related to such a necessary mechanotransduction protein in worms called MEC-2. This study therefore provides the first evidence for a touch receptor gene in mammals and shows that molecules may in the future prove to be important therapeutic targets for the control of chronic pain.

###

*A stomatin-domain protein essential for touch sensation in the mouse

Christiane Wetzel1, Jing Hu1,5, Dieter Riethmacher2,5, Anne Benckendorff1,5, Lena Harder1, Andreas Eilers1, Rabih Moshourab1, Alexey Kozlenkov1, Dominika Labuz3,Ombretta Caspani3, Bettina Erdmann4, Halina Machelska3, Paul A. Heppenstall1,3, and Gary R. Lewin1

1 Growth Factors and Regeneration Group, Max-DelbrГјck Center for Molecular Medicine and CharitГ© UniversitГ¤tsmedizin Berlin, Robert-RГ¶ssle-Str. 10, Berlin-Buch D-13125 Germany.

2 Zentrum fГјr Molekulare Neurobiologie, UniversitГ¤t Hamburg, Falkenried 94, 20251 Hamburg, Germany.

3 Klinik fГјr Anaesthesiologie und Operative Intensivmedizin, CharitГ© UniversitГ¤tsmedizin Berlin, Campus Benjamin Franklin,Hindenburgdamm 30, D-12200 Berlin, Germany.

4 Electronmicroscopy, Max-DelbrГјckCenter for Molecular Medicine, Robert-RГ¶ssle-Str. 10, Berlin-Buch D-13125 Germany.

5 These authors made an equal contribution.

Contact:
Barbara Bachtler
Max DelbrГјck Center for Molecular Medicine (MDC) Berlin-Buch
Robert-RГ¶ssle-StraГџe 10; 13125 Berlin; Germany
details here

For further information please go to:
Max DelbrГјck Center for Molecular Medicine

Mutations Can't Go All The Way In Paget Disease

2007-04-16T08:10:00.001-07:00

Paget disease is a bone disease that results in enlarged bones and causes bone pain, arthritis, deformities, and fractures. It mostly affects individuals over the age of 40 and has a hereditary component. One gene that is mutated in approximately one third of patients with hereditary Padget disease is p62 (sequestosome 1). However, it has not been clear whether mutations (such as the common p62P392L mutation) in this gene actually cause Paget disease.

In a study appearing online in advance of publication in the January print issue of the Journal of Clinical Investigation, Noriyoshi Kurihara and colleagues from the VA Pittsburgh Healthcare System show that expression of the p62P392L mutation causes abnormal development of human bone cells in vitro and mouse bone cells in vivo but does not cause a Padget-like disease in mice. Specifically, expression of p62P392L in the precursors of human bone cells known as osteoclasts (the cells that destroy bone) caused them to be more responsive to factors that drive osteoclast development. Similarly, expression of p62P392L in osteoclast-lineage cells in mice resulted in increased numbers of osteoclasts. Although increased numbers of osteoclasts is a feature of Paget disease, it is not the full range of characteristics. This study therefore suggests that although mutations in p62 predispose an individual to developing Paget disease, other factors are required for the full development of Paget disease.

TITLE: Mutation of the sequestosome 1 (p62) gene increases osteoclastogenesis but does not induce Paget disease

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JCI table of contents: Dec. 21, 2006

AUTHOR CONTACT:
Noriyoshi Kurihara
VA Pittsburgh Healthcare System and University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Contact: Karen Honey
Journal of Clinical Investigation

Pain Relief Effectiveness Down To Mind-Set?

2007-04-16T07:12:00.001-07:00

Research by the Human Pain Research Group at The University of Manchester suggests that people's responses to placebo or "dummy" pain relief varies according to their way of thinking.

40 pain-free volunteers took part in an experiment funded by the Arthritis Research Campaign using an artificial pain stimulus, and were led to expect reduced pain after the application of a cream which was actually a placebo.

Lead researcher Alison Watson said: "Any medical treatment involves a placebo element; the psychological suggestion that it is going to work. So we theorised that a proportion of any treatment's effectiveness would relate to how much we wanted it to work, believed in it or trusted the person administering it.

"Doctors and nurses can transmit a lot of information about a treatment and its effectiveness through their words and gestures. We know that when people visit their preferred GP the treatment or advice they receive will be more effective than that given by a GP they prefer not to see. Similarly, red pills have been shown to be more effective than green ones; so we wanted to test whether all this was due to expectations of successful treatment and trust in the person giving it."

24 of the volunteers initially received a moderately painful heat stimulus to both arms. The placebo cream was then applied to the skin, but they were led to believe that the cream on one of their arms may be a local anaesthetic.

After the application of the cream, the intensity of the heat stimulus was turned down on one arm without informing the volunteer. Subsequently the intensity was returned to its previous level, but - in contrast to the 16 people in the control group - 67% of the treatment group continued to perceive the heat as less painful.

Alison said: "The expectation of pain relief leads to a release of endorphins, the brain's natural pain killers, which is likely to contribute to a sensation of reward and well-being.

"Interestingly, there was an exact split in the range of responses to the placebo; a third of people reporting a reduction in the pain intensity in the "treated" arm only, another third in both arms and the remainder's intensity-ratings not being influenced by the application of the cream. The different responses can be related to the different levels of pain relief the volunteers expected, which may have allowed their individual suggestibility to influence their assessment of the pain experience.

"Our findings suggest that different individuals may have different styles of placebo response, which is likely to affect how they respond to real treatments too. Understanding these differences could better inform the way doctors and nurses provide treatments in the future.

"It could also facilitate more effective clinical trial design, which could substantially reduce the costs of developing new pain killers for patients with conditions like cancer and arthritis.

"A further, exciting possibility is that we could develop talking and drug-based therapies to enhance people's response to placebos. The experimental methods we're using will allow us to test out such possibilities as a method of treating pain."

###

A copy of the full paper, published in the Elsevier journal Pain, is available upon request.

For further information

Mikaela Sitford:

Jo Nightingale:

The University of Manchester (http://www.manchester.ac.uk/) is the largest single-site higher education institution in the country, with 24 academic schools, over 5200 academic and research staff and around 36 000 students. It was awarded University of the Year by the Times Higher Educational Supplement in 2005 and The Sunday Times in 2006, and receives more undergraduate applications than any other UK university.

Its Faculty of Medical & Human Sciences (www.mhs.manchester.ac.uk) is one of the largest faculties of clinical and health sciences in Europe, with a research income of around ВЈ51 million (almost a third of the University's total research income). The School of Medicine http://www.mhs.manchester.ac.uk/) is the largest of its five Schools, encompasses five teaching hospitals and is closely linked to general hospitals and community practices across the North West of England.

The Arthritis Research Campaign (arc), founded in 1936, raises funds to promote medical research into the cause, treatment and cure of arthritic conditions: to educate medical students, doctors and allied healthcare professionals about arthritis and to provide information to people affected by arthritis and to the general public. arc is the only major medical research charity in the UK investigating arthritis in all its forms. Millions of pounds are provided every year for grants funding research, education and training.

Contact: Mikaela Sitford
University of Manchester

Physical Therapists Can Help Relieve Pain

2007-04-16T07:07:00.001-07:00

In light of proposed sterner warning labels for acetaminophen, aspirin, and ibuprofen by federal health officials, patients may wish to consider the benefits of physical therapist intervention for pain relief from certain conditions, according to the American Physical Therapy Association (APTA).

"Many people are looking for alternatives to the sole use of medication to deal with painful conditions," said APTA President R Scott Ward, PT, PhD. "Pain medication may help you get through periods of severe pain, but it won't always help you eliminate the underlying cause of some kinds of pain. For many individuals, it is the underlying causes such as poor posture and alignment, weak and/or inflexible muscles, or tight joint structures that actually exacerbate the painful condition," Ward explained. "A physical therapist will perform a complete musculoskeletal examination and design an individualized treatment program to reduce pain and improve function."

There are many types of pain and inflammation that can be reduced by physical therapist intervention. For example, chronic pain in the back, shoulder, or knee, or pain associated with certain degenerative diseases such as osteoarthritis, can be reduced with the appropriate combination of medication and exercise. "The physical therapist, in collaboration with the patient and the patient's physician, can help the patient manage his or her health over the long term," explained Ward.

For pain of a "mechanical" origin such as back, shoulder, or knee pain, physical therapist intervention may include therapeutic exercise, manual therapy, and functional training. "The goal of the physical therapist is to reduce pain, improve the ability to perform daily activities, and help the patient return to doing the things he or she likes to do," said Ward. "It is also true that patients may unknowingly contribute to their own pain, such as by exercising improperly or with poor posture, and physical therapists can identify and help to correct those behaviors." Ward added, "Through the use of home programs designed to fit the patient's needs, the physical therapist can efficiently progress the patient's rehabilitation and teach the patient how to prevent a recurrence of the original condition."

For osteoarthritis, a degenerative disease of the cartilage and bone, physical therapist intervention may include exercises for strength, flexibility, range of motion, and the use of devices designed to rest or support the joint, such as orthotics or splints.

Physical therapists, who treat nearly 1 million people every day, work with individuals to prevent the loss of mobility before it occurs by developing fitness- and wellness-oriented programs for healthier and more active lifestyles. Many insurance policies also cover post-rehabilitation gym programs. "Most people who desire a fitness plan are not athletes," Ward explained. "They are 'ordinary people' who exercise lightly to moderately. Many have a prior health condition, such as chronic low back pain, that can benefit greatly from physical therapist management focused on increasing muscle strength and endurance, restoring and improving range of motion in joints, increasing cardiovascular endurance, and decreasing muscle and joint pain." The physical therapist individualizes exercise programs based on functional limitations as a result of injury or illness.

For more information on physical therapy or to find a physical therapist near you, please visit http://www.apta.org/consumer.

The American Physical Therapy Association (http://www.apta.org) is a national professional organization representing more than 70,000 physical therapists, physical therapist assistants, and students. Its goal is to foster advancements in physical therapy practice, research, and education.

American Physical Therapy Association
http://www.apta.org

Is Workers' Comp Fair? Research Finds No Link Between Cash Settlements, Future Impairment

2007-04-16T06:20:00.001-07:00

People who receive higher disability ratings for work-related back injuries don't necessarily fare worse over the long term than those who get lower ratings, a Saint Louis University study finds.

The study, which reinforced previous research showing blacks receive less treatment for their back pain than whites, was published online this month in the Journal of Pain. The new research is among the first to examine the relationship between Workers' Compensation settlements for back pain and long-term functional outcomes.

"A disability rating is supposed to reflect the amount of impairment a person has at the time that a case is closed. The presumption is that levels of impairment are stable and related to day-to-day levels of function. I was shocked that the associations between disability rating and subsequent levels of function weren't stronger," said Raymond Tait, Ph.D., professor of psychiatry at Saint Louis University School of Medicine.

Disability ratings also differed between African-Americans and Caucasians. According to Tait, those differences probably reflected differences in treatment: whites were four times more likely to have surgery than blacks. Thos who had surgery received larger settlements for their injuries, Tait said.

"While surgery inflated disability ratings, there appeared not relationship between surgery outcomes and how a person did thereafter," he said.

Tait and colleague John Chibnall, Ph.D., also a professor of psychiatry at Saint Lois University, looked at about 1,500 Missouri workers - 580 African-Americans and 892 Caucasians - whose Workers' Compensation claims for lower back pain were settled between Jan. 1, 2001 and June 1, 2002.

Researchers interviewed the employees 21 months after their settlements about how they were doing. They asked questions about pain intensity, general physical and mental health and whether they currently were working.

Tait and Chibnall said that their findings "raise questions about both the validity and the fairness of the current disability determination program. Disability settlements are designed to give people money toward a fresh start. Those settlements do not appear to reflect the residual levels of disability that people actually experience."

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Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.

Contact: Nancy Solomon
Saint Louis University

First Look At Sickle Cell Disease Hospitalizations In 10 Years

2007-04-16T06:10:00.001-07:00

The first federal analysis in a decade of sickle cell disease hospitalizations shows that admissions of adults remained stable from 1997 to 2004. In 2004, roughly 83,000 hospital stays were for adults and 30,000 were for children. Of the latter, 2,000 stays were for infants, according to the latest News and Numbers issued by the Agency for Healthcare Research and Quality.

Sickle cell disease, an inherited blood disease mostly affecting African Americans, causes red blood cells to lose their shape, block circulation and cause organ damage. The illness has no common cure and patients with periodic pain are often treated with pain medications.

The study found:

-- Patients spent about 5 days in the hospital, which cost facilities an average of $6,223 per stay. Total hospital costs were nearly $500 million overall in 2004

-- Medicaid paid for 65 percent of the stays of patients hospitalized primarily for sickle cell disease, Medicare paid 13 percent, private insurers were responsible for 15 percent, and 4 percent were uninsured.

-- The number of persons with sickle cell disease who died while hospitalized in 2004 was relatively low -- 699 adults and 47 children. In-hospital deaths for children remained low and constant from 1994 to 2004.

This News and Numbers is based on data in Sickle Cell Disease Patients in U.S. Hospitals, 2004, HCUP Statistical Brief # 21.В The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of all short-term, non-federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type as well as the uninsured.

http://www.ahrq.gov

Headaches Form Over A Possible New Form Of Aspirin

2007-04-16T03:41:00.001-07:00

New scientific insights into the packaging of molecules in solids may tempt jokesters to add a second line to that old medical axiom, "Take two aspirin and call me in the morning." Insiders familiar with an unfolding controversy about aspirin -- more than 100 billion tablets of which are produced worldwide each year -- might quip, "Well, doctor, should I take Form I or Form II?"

An article schedule
d for the Jan.1 issue of Chemical & Engineering News, the ACS' weekly newsmagazine, discusses the controversy that has arisen since 2006, when scientists isolated, described and filed a patent for a putative new form of aspirin. Written by C&EN senior editor Ivan Amato, the article describes subtle differences in the crystal, or internal, structures of familiar acetylsalicylic acid and the newly described Form II of aspirin.

The article explains that the discovery of Form II may not have any practical implications for people who take aspirin. However, uncertainties about Form II do showcase surprising knowledge gaps in organic chemists' understanding of the solid state of matter, Amato writes. Those gaps are apparent at a time when pharmaceutical companies are recognizing that minuscule differences in the crystal structures of drugs can have big influences on how drugs work in patients.

ARTICLE #5

"Aspirin's Dose of Structural Insight: A recently identified crystal packing of aspirin is reminding chemists that discoveries lurk in the most familiar places"

FOR FULL TEXT, CONTACT:

Michael Bernstein
ACS News Service

###

ACS News Service Weekly PressPac -- Dec. 20, 2006

The American Chemical Society -- the world's largest scientific society -- is a nonprofit organization chartered by the U.S. Congress and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.

Contact: Michael Woods
American Chemical Society

Patients With PTSD Experience Less Pain Sensitivity -- May Be Related To Altered Processing

2007-04-16T03:36:00.001-07:00

Patients with posttraumatic stress disorder show reduced pain sensitivity, a pattern that may be related to altered pain processing in the brain, according to a report in the January issue of the Archives of General Psychiatry, one of the JAMA/Archives journals.

Posttraumatic stress disorder (PTSD) is an anxiety disorder that may occur in individuals exposed to a traumatic event. It is characterized by chronic arousal, re-experience of the event, and avoidance of stimuli related to the event, according to background information in the article. To the authors' knowledge, no functional imaging study has explored whether patients with PTSD experience and process pain in a different way than control subjects.

Elbert Geuze, Ph.D., of Central Military Hospital and the Rudolph Magnus Institute of Neuroscience, Utrecht, the Netherlands, and colleagues conducted a study to examine neural correlates of pain processing in patients with PTSD. Twelve male Dutch veterans with PTSD and 12 male veterans without PTSD were recruited and matched for age, region of deployment and year of deployment. The experimental procedure consisted of psychophysical assessment and neuroimaging with functional magnetic resonance imaging (fMRI)--the use of magnetic resonance imaging to learn which regions of the brain are active in a specific function. During fMRI, the patients rated the pain they experienced from fixed and variable temperatures applied to their hands.

"Patients with PTSD rated temperatures in the fixed-temperature assessment as less painful compared with controls," the authors report.

"Before fMRI, patients with PTSD already showed a significant reduction in pain sensitivity," the authors write. "During imaging, patients with PTSD rated a fixed temperature as significantly less painful than control veterans." Patients with PTSD showed altered pain processing in brain areas associated with mood and cognitive pain processing.

"These data provide evidence for reduced pain sensitivity in PTSD. The witnessed neural activation pattern is proposed to be related to altered pain processing in patients with PTSD," the authors conclude.

###

(Arch Gen Psychiatry. 2007;64:76-85.)

This study was supported by the Dutch Ministry of Defense. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Elbert Geuze, Ph.D.
JAMA and Archives Journals

Mayo Clinic Successfuly Separates Conjoined Baby Twins Abby And Maddy

2007-04-16T02:53:00.001-07:00

Conjoined 5-month old twins, Abygail and Madysen Fitterer from North Dakota, have been successfully separated by surgeons at Minnesota's Mayo Clinic. Doctors say they are doing well.

The surgery took 6 hours and involved a large team of 40 surgeons and nursing staff, led by Christopher Moir, the lead surgeon.

Abygail and Madysen's parents, Stacy and Suzy Fitterer, of Bismarck, North Dakota, in a webcast news conference released earlier today, expressed their joy at the successful outcome and thanked the doctors and nurses and all their supporters. Also present was their two and half year old son, Nicholas.

Dr. Moir said that it had been a very emotional day, but that the operation had been "flawless" and "went exactly as we had hoped, and exactly as we had planned. Abby and Maddy are still together in our hearts, in our minds and in our spirits, and right now they are up in the ICU together working their hardest after a long but very successful operation".

Dr. Moir described the surgical challenges of the operation with the aid of life-sized models of the babies' ribcages and chest cavities. There were two sets of models: one set for before the separation and another set for afterwards. The models had been created by the Mayo clinic's department of engineering and their team of medical illustrators.

Using the life-sized models the surgical team was able to plan the surgery and the reconstruction in great detail in advance.

Much of the operation involved separating the chest and abdominal walls that were conjoined, and then the separation of the major organs. The hearts had to be repositioned and the chest walls reconstructed. Also, the babies shared one liver, but this could be divided because there were separate drainage systems.

As the baby girls were joined at the chest, their hospitalization had to start nearly 100 days earlier, in June 2006, when they were just 8 weeks old. This was when they had their first operation, it lasted 4 hours and involved placing chest expanders under the skin on their shared chest wall.

Over the following 3 months, the chest expanders caused the skin and muscle around the chest wall to stretch and regrow. If the skin and muscle is not stretched it is not possible to close the hole left after separation.

The operation to separate the twins started at 09.50 AM (CST), and they were placed on separate operating tables, ready for chest reconstruction at 12.27. The Mayo Clinic video shows the surgical team applauding as the girls are placed on the tables.

The Mayo Clinic has performed four previous separations of conjoined twins. According to their press release, conjoined twins can occur in one in 50,000 pregnancies, but they account for only 1 in 250,000 live births.

Abygail and Madysen Fitterer's webpage (Caringbridge).

Written by: Catharine Paddock
Writer: Medical News Today

DURECT Starts Phase II Dosing For TRANSDUR(TM)-Bupivacaine (DUR-843)

2007-04-16T02:42:00.001-07:00

DURECT Corporation (Nasdaq: DRRX) today announced that we have started Phase II dosing in the U.S. under an FDA-accepted Investigational New Drug (IND) application for TRANSDUR(TM)-Bupivacaine (DUR-843), a transdermal pain patch for patients suffering from Post-Herpetic Neuralgia (post-shingles pain or PHN).

DURECT's Phase I trial for TRANSDUR-Bupivacaine, initially reported on December 11, 2006, demonstrated good safety, tolerability and drug release for up to 3 days. TRANSDUR-Bupivacaine is intended to provide up to 3 days of pain relief for patients suffering from PHN, as compared to a wearing time limited to 12 hours with currently available patches.

"The initiation of the Phase II program for TRANSDUR-Bupivacaine is an important milestone for us," said James E. Brown, DURECT's President and CEO. "Based on our TRANSDUR technology, we believe that the product profile of TRANSDUR-Bupivacaine represents an improvement over existing pain control products for patients suffering from PHN."

DURECT's Phase II program for TRANSDUR-Bupivacaine has begun with a randomized, multi-center, double-blind, placebo controlled, two-way crossover trial in approximately 50 patients with PHN to assess safety as well as the magnitude, duration and characteristics of analgesic activity of TRANSDUR- Bupivacaine.

Bupivacaine, the active agent in TRANSDUR-Bupivacaine, is a potent, FDA- approved long-acting local anesthetic used in regional anesthesia including infiltration, nerve block, epidural and intrathecal anesthesia. Bupivacaine is a more potent sodium channel blocker and has a longer duration of action than lidocaine, the active ingredient for Lidoderm(R), the market leader for post- herpetic neuralgia pain management.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com/.

TRANSDUR(TM) is a trademark of DURECT Corporation. TRANSDUR- Bupivacaine is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT's products in development including TRANSDUR-Bupivacaine and product development plans are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's (and that of its third party collaborators where applicable) abilities to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 3, 2006 under the heading "Risk Factors."

DURECT Corporation
http://www.durect.com/

Victory Pharma, Inc. Announces Investigational New Drug MGX-006 Approved By The FDA

2007-04-16T01:51:00.001-07:00

Victory Pharma, Inc. announced today the U.S. Food and Drug Administration (FDA) completed its review for the company's Investigational New Drug (IND) application to evaluate MGX-006, a unique formulation of a currently marketed agent with indications for various nausea and vomiting conditions. The MGX-006 program is being supported via a co-development agreement between Victory and its technology partner signed in August of 2006. Upon regulatory approval, Victory intends to market the product through its proprietary U.S. based sales organization.

"MGX-006 emerged from our strategy to develop and acquire products utilized for the treatment of pain or pain-related illness," said Dave Gonyer, Vice President of Commercial Development for Victory Pharma. "Many patients who experience pain also experience nausea due to the disease state itself or the treatments for it. We believe that MGX-006 could provide a significant improvement to the treatment of nausea and vomiting and substantially improve compliance to benefit patients."

The successful initiation of a second development program represents an important milestone in Victory's evolution into a leading pain and related specialty pharmaceutical company. The anti-nausea market remains an area of unmet medical need with expanding market potential. Many anti-emetics are used concomitantly with pain products, and are often prescribed by Victory's target audiences for its current product portfolio. MGX-006 is targeted to enter pivotal trials in 2007 in conjunction with a leading clinical research organization.

About Victory Pharmaceuticals

Victory Pharma, Inc. is a private San Diego based specialty pharmaceutical company focused on acquiring, marketing and developing proprietary late stage pain and related products. Victory markets its existing pain products through its physician-based field sales force deployed throughout the U.S. The Company is developing several products in pain and pain complementary markets including MGX-001, for treatment of chronic severe pain and a commonly associated opiate-induced side effect. MGX-001 is currently in Phase II clinical testing in the United States.

Further information regarding Victory is available at http://www.VictoryPharma.com.

Victory Pharma, Inc.
http://www.VictoryPharma.com

MRI Of The Ankle Changes Patient Treatment And Improves Referring Physician Confidence In Diagnosis

2007-04-16T01:41:00.001-07:00

MR imaging can make a dramatic difference in the management of patients with ankle pain, changing treatment in about one-third of the patients, a new study finds.

The study, of 91 patients, found that MR changed the management plans of 35% of patients, said Philip W.P. Bearcroft, MD, of Cambridge University Hospitals in England. "This is itself is significant, but more significant is the fact that before an MRI was done, 65 of the 91 patients were scheduled to undergo surgery. After an MRI was done, nine of those patients were treated nonsurgically," Dr. Bearcroft said.

Dr. Bearcroft and his colleagues conducted the study in conjunction with an orthopedic foot and ankle surgeon at a regional teaching hospital. The surgeon noted his proposed treatment plan for each patient before and after an MR examination. The surgeon also noted the potential diagnoses for each injury. Before an MR examination was done, the surgeon indicated an average 2.3 possible diagnoses per patient. "After MRI was performed, the number of diagnoses per patient was reduced to 1.2," said Dr. Bearcroft. MRI increased the referring physician's confidence in his diagnoses, Dr. Bearcroft said. "In 66% of the MRI examinations performed, the referring surgeon felt that his understanding of the patient's disease had either depended upon or had been substantially improved by MRI," he added.

"This study is a bit different than the traditional radiological study," Dr. Bearcroft said. "Most studies relate to improving technique or look at the accuracy and predictive value of imaging techniques. This one was designed to determine if we really make a difference to the referring physician and the patient," he said.

The study appeared in a recent issue of the American Journal of Roentgenology, published by the American Roentgen Ray Society.

American Roentgen Ray Society (ARRS)
44211 Slatestone Ct.
Leesburg, VA 20176-5109 United States
http://www.arrs.org

Horizon Therapeutics Announces Special Protocol Assessment With FDA For Phase 3 Trial Program

2007-04-16T00:45:00.001-07:00

Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) via a Special Protocol Assessment for the Phase 3 trial program of HZT-501, its "GI-friendly" prescription NSAID for mild-to-moderate pain relief.

The SPA agreement indicates that if the trials successfully meet their primary endpoint, the data will provide support for an efficacy claim in a marketing application to the FDA. The two trials are expected to begin patient enrollment in the first half of this year.

HZT-501 is a proprietary formulation of the world's most prescribed non-steroidal anti-inflammatory drug (NSAID) ibuprofen, combined with the most potent H2 receptor antagonist famotidine, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for ulceration. In a randomized pilot clinical study published in The New England Journal of Medicine (Taha, et. al May 1996), famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers vs. placebo when administered with NSAIDs.

"While NSAID's provide excellent pain relief, they can cause serious gastrointestinal side effects such as ulcers," said Dr. Loren Laine, Keck School of Medicine of the University of Southern California. "This is an important medical issue, especially given data from studies that suggest that many patients at risk do not receive appropriate therapy. HZT-501 was designed with the specific goal of decreasing the GI injury associated with NSAID's."

Phase 3 Clinical Study

The Phase 3 program will comprise two trials involving a total of 1,200 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon Protocol HZ-CA-301 and HZ-CA-303 will evaluate the efficacy and safety of HZT-501 with a primary endpoint of reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require the use of ibuprofen.

The clinical trials will be multi-center, randomized, controlled, and blinded for up to 24 weeks of treatment, followed by a 4 week safety evaluation period. The studies will be conducted in the United States.

Horizon has successfully completed product development and early supportive clinical studies on HZT-501 necessary to begin Phase 3 trials including PK/PD formulation design, drug-drug interaction, and comparative bioavailability of HZT-501 to approved reference drug products.

"The SPA is a major milestone that solidifies what we believe is a clearly defined development and regulatory pathway to address this significant unmet medical need," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "In addition to HZT-501, we are building a pipeline of therapies through similar combinations of existing pharmaceutical products that offer the potential for rapid development and commercialization with relatively low risk."

Proof-of-concept

In the May 30, 1996 edition of the New England Journal of Medicine, an article, "Famotidine for the Prevention of Gastric and Duodenal Ulcers Caused by Non-steroidal Anti-inflammatory Drugs" was published by Taha, et. al. The study was a randomized, controlled trial including 285 arthritis patients. The primary endpoint was the measurement of the cumulative incidence of endoscopically diagnosed gastric and duodenal ulcers at 4, 12 and 24 weeks in patients treated with an NSAID alone vs. those treated with NSAID plus a total daily dose of either 40mg or 80mg of famotidine.

The cumulative incidence of gastric ulcers was 20% in the NSAID-alone group and 8% in the 40-mg BID (twice daily) famotidine plus NSAID group (p = 0.03). The cumulative incidence of duodenal ulcers was 13% in the NSAID-alone group and 2% in the 40-mg BID famotidine plus NSAID group (p = 0.01). There were also significantly lower rates of gastric and duodenal ulceration when analyzed separately and when combined (28% for the NSAID-alone group vs. 11% for the 40-mg BID famotidine plus NSAID group; p = 0.003).

About the Pain Market

HZT-501 targets the widespread product void in the mild-to-moderate pain market left by COX-2 inhibitors such as Vioxx(R), which have either been taken off the market or prescribed less frequently due to elevated cardiovascular risk. In 2005, the U.S. non-steroidal anti-inflammatory (NSAID) market grew over 20 percent to 73 million prescriptions. Over 26 million ibuprofen prescriptions are now written annually in the U.S. alone.

However, while commonly prescribed to treat pain, NSAIDs have been linked to serious gastrointestinal (GI) side effects in up to 25 percent of all chronic arthritis patients. NSAID-induced GI toxicity causes an estimated 16,000 deaths and more than 100,000 hospitalizations annually in the United States. Despite this, studies have shown that as low as 30% of high-risk patients are commonly co-prescribed a gastro-protective agent in combination with their NSAID to prevent or relieve side effects. In addition, patient adherence to a regimen of separate GI and pain medications has also been shown to be poor.

About Horizon Therapeutics

Horizon Therapeutics, Inc. is a late stage biopharmaceutical company focused on the rapid development and commercialization of therapeutic treatments for mild-to-moderate pain management. The Company is building a novel portfolio of therapies through innovative combinations of approved pharmaceutical products that seek to improve safety, efficacy, and patient compliance. Its lead product candidate, HZT-501, will enter Phase 3 trials in 2007. In addition to HZT-501, Horizon has a pipeline of follow-on pain combination products in earlier stages of development. For more information visit http://www.horizontherapeutics.com.

Horizon Therapeutics, Inc.
http://www.horizontherapeutics.com

Anesiva Announces Clinical Plan For Pivotal Testing Of 4975, Long-Acting Pain Candidate

2007-04-16T00:38:00.001-07:00

Anesiva, Inc. (Nasdaq: ANSV) today outlined the planned Phase 2/3 clinical trial program for the development of 4975, the company's long-acting, non-opioid drug candidate for the acute treatment of severe pain. After a successful meeting with the FDA, the company will be focusing its near-term development efforts of 4975 in two areas-post-surgical pain and osteoarthritis.

In initial Phase 2 studies, 4975 was shown to provide a statistically significant reduction in the pain associated with total knee replacement surgeries and osteoarthritis of the knee for weeks to months following a single application. Anesiva anticipates commencing a series of clinical trials during the first half of this year to confirm the safety and efficacy of 4975. Following is a list of trials that are planned for the company's post-surgical and osteoarthritis indications:

Post-surgical

-- A 50-patient Phase 2 trial evaluating a higher dose of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 1H07)

-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with hip replacement surgeries (Begin in 1H07)

-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with arthroscopic shoulder surgeries (Begin in 1H07)

-- A 450-patient Phase 3 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 2H07)

Osteoarthritis

-- A 200-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with osteoarthritis of the knee (Begin in 1H07)

"We are eager to begin the next phase of our development to confirm our earlier findings of 4975, which has shown significant potential to treat debilitating pain in a number of indications without the substantial side effects associated with current opioid pain medications," stated John P. McLaughlin, chief executive officer of Anesiva. "We believe our Phase 2/3 program will provide an overview of the efficacy and safety profile of 4975 to treat pain associated with surgery and osteoarthritis."

How 4975 May Address Need for Long-Duration, Well-Tolerated Pain Relief

4975 is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, 4975 does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure.

In clinical studies to date, 4975 has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated. Opioid drugs, such as morphine, which are commonly used agents to relieve pain in post-surgical and musculoskeletal pain conditions, have significant side effects including sedation, respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use.

About Total Knee Replacement Surgery and Osteoarthritis of the Knee

Total knee replacement (also known as total knee arthroplasty) is performed in patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of restoring or improving patients' quality of life.

Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients' mobility and activities. Approximately 1.1 million patients are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.

There were an estimated 470,000 total knee replacement procedures performed in the United States in 2005, and the number of replacements will continue to grow as the average age of the U.S. population increases and as these individuals conduct more active lives. The American Academy of Orthopedic Surgery projects that approximately 3.5 million of these procedures will be done each year by 2030.

Conference Call Details

Anesiva will conduct a webcast conference call with the investment community at 9:00 a.m. EST, today, January 8, 2007 to discuss the company's clinical trial plans for 4975. Interested parties can listen to the live audio webcast by dialing 877-266-9200 (international dial: 706-634-1538) or by logging on to http://www.anesiva.com and going to the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by dialing 800-642-1687 (international dial: 706-645-9291) and giving the following pass code: 5711122.

About Anesiva

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.

Forward Looking Statements

This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's most recent quarterly report on Form 10-Q.

Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

Anesiva, Inc.
http://www.anesiva.com

Cephalon Announces Positive Results From Two Phase 3 Clinical Trials Of FENTORA(TM) In Breakthrough Pain

2007-04-15T23:40:00.001-07:00

Cephalon, Inc. (Nasdaq: CEPH) today reported data from the first Phase 3 clinical trial to demonstrate positive results of FENTORA(TM) (fentanyl buccal tablet) [C-II] in opioid-tolerant patients with neuropathic pain. Onset of pain relief began in 10 minutes in this study as well as in a separate Phase 3 study in opioid- tolerant patients with cancer. The data from these studies will be submitted for presentation at a medical meeting in 2007.

One double-blind, placebo-controlled study assessed the efficacy of FENTORA in a variety of chronic conditions associated with neuropathic pain. The study involved 75 opioid-tolerant patients and demonstrated statistically significant improvement as measured on the primary endpoint, the Sum of Pain Intensity Differences at 60 minutes (p<0.0001). Statistically significant differences in pain relief compared with placebo were observed as early as 10 minutes (p<0.05), consistent with positive results from a previously announced study in opioid-tolerant patients with chronic low back pain. The medication was generally well tolerated with adverse events typical of opioids.

Similar results were reported for a second double-blind, placebo- controlled study that evaluated the onset of pain relief with FENTORA in 78 opioid-tolerant patients with cancer. Earlier clinical trials submitted as part of the FENTORA New Drug Application began evaluating pain relief at 15 minutes. This new study looked at earlier time points and demonstrated statistically significant differences in pain relief compared with placebo at 10 minutes (p<0.0001). The medication was generally well tolerated with adverse events typical of opioids.

"These new studies of FENTORA provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "These data further suggest that, in opioid-tolerant patients, the onset of pain relief from FENTORA may be more rapid than indicated in the approved labeling."

FENTORA is currently approved by the FDA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. At this time, it is not approved for the management of breakthrough pain associated with other chronic pain conditions. Cephalon expects to seek regulatory approval for an expansion of the labeled indications for FENTORA, which will include data from Phase 3 studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.

Breakthrough Pain

Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. It is estimated that 64 percent of patients with cancer - and 74 percent of patients with conditions other than cancer - who are treated for persistent pain will experience breakthrough pain.

FENTORA

Approved to manage breakthrough pain in opioid-tolerant patients with cancer, FENTORA's drug delivery system generates transient changes in pH that may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. The most commonly observed adverse events seen in all FENTORA clinical studies are typical of opioid adverse events. Opioid adverse events should be expected and managed accordingly. In clinical trials of FENTORA, the most common (.10%) adverse events were nausea, dizziness, vomiting, fatigue, headache, constipation, somnolence, anemia, and dehydration. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.

IMPORTANT WARNINGS AND SAFETY INFORMATION

FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients.

Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children (see Information for Patients and Their Caregivers contained within the prescribing information for disposal instructions).

Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg-per-mcg basis and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).

FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Full prescribing information about FENTORA, including a boxed warning, is available from http://www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855)

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.

The company currently markets six proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including any expansion of the labeled indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients discussed above; prospects for regulatory approval; market prospects for its product; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Cephalon, Inc.
http://www.cephalon.com

Jefferson Cardiologists Fix Broken Heart, Potentially Fatal Complication Of Heart Attack

2007-04-15T23:36:00.001-07:00

Unexplained chest pain after a heart attack might be more dangerous than many physicians originally think.

In a case study to be published in the January issue of the international journal Clinical Cardiology, physicians at Thomas Jefferson University Hospital in Philadelphia report on a seemingly healthy 55-year-old man who had a silent heart attack and subsequent unexplained chest pain.

Once he was admitted to the hospital, it was discovered that the man actually had a rarely diagnosed complication called subepicardial aneurysm, which, if not quickly treated, could be fatal.

"The chest pain was a rupture of the heart wall about to happen--the most feared complication of a heart attack," explains Michael Savage, M.D., director, Cardiac Catheterization Laboratory at Thomas Jefferson University Hospital. "The rupture occurs from a tear in the muscle that has already been damaged by a heart attack. The heart muscle breaks and the wall bursts usually causing cataclysmic death soon after."

The Jefferson researchers recommend that when a patient experiences unexplained pain after a heart attack, physicians should consider the possibility of a subepicardial aneurysm.

Diagnosis of a subepicardial aneurysm is extremely rare, says Dr. Savage, who is also associate professor of Medicine, Jefferson Medical College of Thomas Jefferson University. Only 20 cases have ever been reported in the medical literature and many patients were diagnosed after death. It is highly likely that many more patients have died from this complication but the cause of death was unrecognized.

According to lead researcher, Aaron Giltner, M.D., a cardiology fellow at Thomas Jefferson University Hospital, the man, who worked in construction, came to the Thomas Jefferson University Hospital emergency room with chest pain. A heart attack was initially considered and the emergency physicians called in the interventional cardiologists for a consult.

The cardiologists also initially suspected a heart attack. The patient was admitted to the hospital and was readied for a cardiac catheterization to check for blocked arteries.

The cardiac catheterization suggested a subepicardial aneurysm--an impending cardiac rupture--and the researchers arranged for a CT scan. This confirmed that the patient had a subepicardial aneurysm, a rarely diagnosed complication of a heart attack. Once the problem was identified, surgeons promptly repaired the heart, saving his life.

"As our study shows," Dr. Savage says, "CT imaging can be invaluable in establishing the diagnosis of a subepicardial aneurysm. Clinical recognition of this entity and the use of appropriate imaging modalities are imperative to facilitate life-saving surgical intervention."

###

Members of the Jefferson University team who conducted this study are: Aaron Giltner, M.D., Ethan J. Halpern, M.D., Daniel Marelli, M.D. and Michael P. Savage, M.D.

Contact: Nan Myers
Thomas Jefferson University

Caffeine Cuts Post-Workout Pain By Nearly 50 Percent, UGA Study Finds

2007-04-15T22:41:00.001-07:00

Although it's too soon to recommend dropping by Starbucks before hitting the gym, a new study suggests that caffeine can help reduce the post-workout soreness that discourages some people from exercising.

In a study to be published in the February issue of The Journal of Pain, a team of University of Georgia researchers finds that moderate doses of caffeine, roughly equivalent to two cups of coffee, cut post-workout muscle pain by up to 48 percent in a small sample of volunteers.

Lead author Victor Maridakis, a researcher in the department of kinesiology at the UGA College of Education, said the findings may be particularly relevant to people new to exercise, since they tend to experience the most soreness.

"If you can use caffeine to reduce the pain, it may make it easier to transition from that first week into a much longer exercise program," he said.

Maridakis and his colleagues studied nine female college students who were not regular caffeine users and did not engage in regular resistance training. One and two days after an exercise session that caused moderate muscle soreness, the volunteers took either caffeine or a placebo and performed two different quadriceps (thigh) exercises, one designed to produce a maximal force, the other designed to generate a sub-maximal force. Those that consumed caffeine one-hour before the maximum force test had a 48 percent reduction in pain compared to the placebo group, while those that took caffeine before the sub-maximal test reported a 26 percent reduction in pain.

Caffeine has long been known to increase alertness and endurance, and a 2003 study led by UGA professor Patrick O'Connor found that caffeine reduces thigh pain during moderate-intensity cycling. O'Connor, who along with professors Kevin McCully and the late Gary Dudley co-authored the current study, explained that caffeine likely works by blocking the body's receptors for adenosine, a chemical released in response to inflammation.

Despite the positive findings in the study, the researchers say there are some caveats. First, the results may not be applicable to regular caffeine users, since they may be less sensitive to caffeine's effect. The researchers chose to study women to get a definitive answer in at least one sex, but men may respond differently to caffeine. And the small sample size of nine volunteers means that the study will have to be replicated with a larger study.

O'Connor said that despite these limitations, caffeine appears to be more effective in relieving post-workout muscle pain than several commonly used drugs. Previous studies have found that the pain reliever naproxen (the active ingredient in Aleve) produced a 30 percent reduction in soreness. Aspirin produced a 25 percent reduction, and ibuprofen has produced inconsistent results.

"A lot of times what people use for muscle pain is aspirin or ibuprofen, but caffeine seems to work better than those drugs, at least among women whose daily caffeine consumption is low," O'Connor said.

Still, the researchers recommend that people use caution when using caffeine before a workout. For some people, too much caffeine can produce side effects such as jitteriness, heart palpitations and sleep disturbances.

"It can reduce pain," Maridakis said, "but you have to apply some common sense and not go overboard."

###

Contact: Sam Fahmy
University of Georgia

As Former President George Bush Recuperates From Hip Replacement Surgery, Physical Therapy Will Play Key Role In Recovery

2007-04-15T22:36:00.001-07:00

As former President George H. W. Bush recovers from last week's surgery at the Mayo Clinic to replace his right hip, periodic and progressive physical therapy will play a key role in his successful rehabilitation, says the American Physical Therapy Association (APTA).

"Following hip replacement surgery, physical therapy is routinely used, either in a home health, out-patient, or a rehabilitation setting," says Dale Avers, PT, DPT, PhD, a professor in physical therapy at SUNY Upstate Medical University in Syracuse, NY. Avers, who has been conducting research regarding exercise for aging adults, including those with hip replacements, warns that residual weakness, which can include balance impairment, may become evident even years following hip replacement surgery if not properly addressed.

"Physical therapy, not necessarily on a continuous basis, is now recommended for patients with hip replacements," says Avers. "Starting around 4 months, physical therapy, which includes strength training, mobility and balance exercises, is recommended for optimal results."

The leading indicator for hip replacement is pain and impaired mobility, not age, notes Avers, very often associated with osteoarthritis. Physical therapists can improve mobility and decrease pain through manual therapy and strengthening exercises. Hip replacement surgery is recommended as a last resort, when the pain becomes unbearable and interferes with mobility.

For President Bush, Senator Elizabeth Dole, and other patients with hip replacements, physical therapy starts immediately in the hospital following surgery, beginning with gentle mobility exercises and activities, says Avers. Gradually, the exercises are progressed as healing takes place. Avers said that once the immediate post-op rehabilitation is complete, patients should return to physical therapy for continued strength and balance training. "As healing progresses, they need the guidance of a physical therapist to achieve optimal results and to return to full function in the activities they enjoy," Avers said.

"Successful hip replacement surgery is the first step in President Bush's recovery and to enjoying his normal activities," says Avers. "Physical therapy is the finishing touch."

The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as other physical therapy news and information at http://www.apta.org/consumer.

American Physical Therapy Association
http://www.apta.org

Novel Shingles Pain Treatment Lauched In The UK

2007-04-15T21:39:00.001-07:00

GrГјnenthal announced today that it has been granted a UK licence for its new product Versatis(R) (5% lidocaine medicated plaster). Versatis is licensed for the treatment of neuropathic pain associated with previous herpes zoster (shingles) infection, also known as post-herpetic neuralgia (PHN)1.

Versatis offers a topical and non-systemic approach for the treatment of localised neuropathic pain symptoms associated with PHN, often described as burning, shooting or stabbing. It is an innovative combination of the local anaesthetic lidocaine and a soft hydrogel plaster, combining efficacious treatment and simple handling with a proven tolerability and safety profile1.

The plaster offers rapid and continuous pain relief 30 minutes after application2. Following a once daily 12 hours-on/12 hours-off application schedule, up to three plasters can be used at one time. It can be used as monotherapy or in combination with patient's existing analgesia, and clinical trials have shown no clinically relevant drug interactions1.

The launch of Versatis coincides with the announcement of a new survey that shows the impact of PHN on quality of life. Conducted by the Barts Pain Research Group, the survey reveals that over 80% of respondents felt that PHN had negatively affected their ability to enjoy life, whilst almost 50% felt suicidal or depressed as a result of PHN3. Apart from the psychological impact of PHN, the condition has a significant impact on day-to-day activities, such as work, sleep and even getting dressed with one in three people not being able to participate in any day-to-day activities prior to treatment3. In addition, 92% of patients continued to suffer pain even whilst on treatment and over two thirds are dissatisfied with existing treatment options3.

"Versatis offers clinicians an effective and well-tolerated new treatment option for people suffering the debilitating shooting, stabbing and burning pain symptoms following shingles," said Professor Richard Langford, Professor of Anaesthesia & Pain Medicine at St Bartholomew's Hospital London. "It is generally older people who develop post-herpetic neuralgia after shingles and hence with their multiple morbidities and medications, the very low systemic level of lidocaine during Versatis use, minimises concerns about contraindications and drug interactions."

More than one million patients have been treated with the lidocaine plaster since 1999 in the US4. Marketed as Lidoderm(R) by Endo Pharmaceuticals its use demonstrates improved quality of life5 and better pain relief6 compared to their other treatments.В

GrГјnenthal researches, develops and produces high therapeutic value medicines and markets them throughout the world. GrГјnenthal is an expert in drugs for pain therapy and gynaecology and a leader in the field of intelligent, user-friendly drug delivery technologies. GrГјnenthal is an independent, family-owned company with a long history of international co-operations. The company was founded in 1946 and has its headquarters in Germany. We supply our markets from seven production sites around the world and have affiliates in 27 countries. GrГјnenthal employs about 1,900 people in Germany and about 4,700 world-wide. Sales in 2005 amounted to approximately 777 million Euro.

-- Post-herpetic Neuralgia (PHN) is a prolonged neuropathic or nerve pain that follows an acute attack of shingles.

-- Shingles or herpes zoster is an acute infection caused by the reactivation of the latent varicella-zoster virus (chickenpox). After a childhood chicken pox infection the virus lies dormant in the dorsal root ganglia of the spinal cord. An acute shingles rash occurs when the virus is reactivated7.

-- PHN affects approximately 200,000 people in the UK8.

-- Older age is the risk factor most strongly associated with developing PHN and people aged 50 years or older are almost 15 times more likely to have pain 30 days after developing a shingles rash increasing to 27 times more likely after 60 days8.

References

1. Versatis Summary of Product Characteristics
2. Rowbotham MC et al. Pain 1996; 65: 39-44
3. The Barts Pain Research Group. Post-herpetic Neuralgia: The patient's voice.
4. GrГјnenthal data on file (Patient exposure)
5. Gammaitoni AR et al. Safety and Tolerability of the Lidocaine Patch 5%, a Targeted Peripheral Analgesic: A Review of the Literature. J Clin Pharmacol 2003;43: 111-117
6. Katz NP et al. Lidocaine Patch 5% Reduces Pain Intensity and Interference with Quality of Life in Patients With Postherpetic Neuralgia. Pain Med 2002; 3(4) 324-332
7. Prodigy Guidance: Shingles and post-herpetic neuralgia
8. Shingles Support Society. Bowsher D. Treatment of post-herpetic neuralgia in the elderlyl

AspenBio Pharma's Human Appendicitis Blood Test Shows Strong Preliminary Results As Clinical Diagnostic Aid

2007-04-15T21:35:00.001-07:00

AspenBio Pharma, Inc. (OTC Bulletin Board: APNB) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, today reported on the development status of the company's human appendicitis blood test and positive results from preliminary clinical trials. The company also reported that U.S. federal trademark applications have been filed for AppyScore and AppyScreen for the planned commercialization of two new human appendicitis blood tests.

AspenBio Pharma continues to make exciting progress in the development and testing of its two first-generation blood-based human diagnostic tests designed to rapidly help diagnose or rule out appendicitis in patients complaining of abdominal pain. AspenBio has created and optimized a specialized assay test to detect a marker in the blood associated with appendicitis and has tested this assay in several on-going research trials involving hundreds of human patients.

Preliminary results indicate that the company's first-generation triage test is highly effective in identifying patients with acute appendicitis. This marker demonstrates a linear (or direct) correlation to the histopathologic severity of appendicitis. The test is especially accurate in patients 30 years of age and under, which is also the age group most commonly afflicted with appendicitis.

As a result of these positive developments, the company's R&D team is designing two separate appendicitis triage blood test systems. The primary test is the AppyScore system which is based on a blood test result scoring system designed to be used as an initial appendicitis triage test for patients entering an Emergency Room /urgent care facility complaining of abdominal pain. The scoring system is designed to quantify the blood marker level, which guides the physician in determining not only the presence but also the stage of appendicitis. Determining the stage of appendicitis helps the physician assess the level of possible danger and the potential for the appendix to burst causing complications of a life-threatening perforation.

The AppyScreen system is a second appendicitis screening test which is being developed as a point-of-care test designed specifically for use in a physician's office. This rapid-screen qualitative blood test would be used by a primary care doctor to quickly screen and identify potential appendicitis patients -- especially children and young adults -- who should immediately go to the emergency room for further appropriate care that may include a more quantitative AppyScore test.

Appendicitis can advance rapidly. Delays in the diagnosis and care of appendicitis are associated with serious complications. After basic tests and examination, a CT scan is the most commonly used emergency room diagnostic method for ruling out appendicitis for patients with abdominal pain. Costing $1,500 to $3,000 per procedure, an estimated $4.5 to $9.0 billion is spent annually in the US on CT scans for this purpose. The scans can take more than four hours to complete and expose patients to ionizing radiation. While CT scans are still the current medical standard, CT diagnostic error rates are estimated to range between 15% and 40%, and a high percentage of CT scan results are simply inconclusive. The present approach contributes to a significantly large number of unnecessary appendicitis surgeries due to diagnostic errors.

Every year in the United States alone, approximately 6 million patients enter emergency rooms complaining of abdominal pain. About 700,000 of these patients are diagnosed with appendicitis and have emergency surgery to remove the appendix. However, due to diagnostic errors some 100,000 of these patients (or approximately one out of seven) who undergo this emergency surgery end up having a normal appendix removed.

In addition to involving other risks, hospital charges for such unnecessary (negative) appendectomies are estimated to give rise to hospital charges of approximately $1.5 billion annually in the US alone. Additionally, about 95,000 patients are not diagnosed correctly in time and suffer a potentially life-threatening perforation of the appendix requiring immediate and more complex emergency surgery. This also results in a more lengthy hospital stay, a longer recovery or treatment period, and substantially increased cost.

"When we first started our investigations to develop this blood test, our main goal was to be able to more accurately identify patients with appendicitis," said Dr. John Bealer, a pediatric surgeon based in Denver Colorado and co-inventor of the test. "In initial clinical studies of patients with appendicitis, AppyScore has been impressively accurate at detecting appendicitis. False-negative results for AppyScore have been exceedingly rare and to date seen only in those cases with minimal histological evidence of appendicitis. This finding opens up the potential of two different roles for AppyScore in treating patients. For some patients, AppyScore could potentially be a stand-alone diagnostic test of appendicitis. For others, it could also be useful as a triage tool by determining which abdominal-pain patients are the best candidates for CT scanning. By both adding new diagnostic information and supplementing standard diagnostic methods, AppyScore could become very important for the 6 million patients annually who enter emergency rooms with abdominal pain."

Appendicitis most frequently occurs in patients aged 10 to 30, but can affect all ages usually presenting as abdominal pain. While this first-generation test can be falsely-positive in some patients with other specific inflammatory diseases, these diseases are infrequent in people less than 30 years of age and generally are less of a diagnostic challenge than appendicitis.

Appendicitis is especially difficult to diagnose in children and young adults using a CT scan because of their low body fat. This lack of body fat results in very poor tissue differentiation on the CT scan. AspenBio Pharma's new triage/diagnostic tests also have the potential to enhance overall safety by reducing the amount of radiation exposure in children from unnecessary CT scans. Adds Bealer, "Given these factors, we are particularly excited about what this triage test could mean for helping to diagnose or rule out the disease in the highest-risk appendicitis population of children and young adults."

Based upon a potential annual emergency room/urgent care usage of 6 million tests and management's estimates of a sales price of a few hundred dollars per test, the annual U.S. market potential for AppyScore and AppyScreen systems could exceed several hundred million dollars, with the international market potential at a multiple of that of the U.S.

"We believe that these two first generation triage tests will prove to be very cost-effective and welcomed innovations for emergency room physicians who must quickly and correctly diagnose or rule out appendicitis," said Richard Donnelly, AspenBio Pharma's president and CEO. "Rarely do you find a new healthcare technology that is faster, more accurate, and much less expensive than current techniques. These blood-based tests can potentially save the US healthcare system and insurance providers billions of dollars in reduced numbers of CT scans alone. Consequently, the AppyScore and AppyScreen tests have legitimate blockbuster sales potential in the human medical markets worldwide."

Beginning in 2004, AspenBio commenced the establishment of an intellectual property portfolio for the appendicitis testing technology and products. The company has filed for worldwide patent coverage related to several aspects of the initial discovery and various test applications. Further enhancement and expansion of the proprietary patent position is ongoing with respect to the scope of protection for the company's first generation and future generation versions of tests. Strong scientific and technical progress remain the basis for these innovative efforts.

Clinical studies will continue, while activities for securing an international licensing partner to support FDA approval, distribution, and marketing will commence in the near future. The company anticipates submitting an FDA regulatory filing for approval of the tests during the third quarter of 2007.

About AspenBio Pharma, Inc.

AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to the discovery, development, manufacture, and marketing of novel proprietary products, including those that enhance the reproductive efficiency of animals and that have large worldwide market potential. The company was originally formed to produce purified proteins for diagnostic applications and has become a leading supplier of human hormones to many of the nation's largest medical diagnostic companies and research institutions. The company has successfully leveraged this foundational science and technology expertise to rapidly develop an enviable late-stage pipeline of several novel reproduction hormone analogs for wide-ranging therapeutic use initially in bovine and equine species. For more information, please visit: http://www.aspenbiopharma.com.

Forward Looking Statements

This news release includes "forward looking statements" of AspenBio Pharma, Inc. ("APNB") as defined by the Securities and Exchange Commission (the "SEC"). All statements, other than statements of historical fact, included in the press release that address activities, events or developments that APNB believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors APNB believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of APNB. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including the ability to successfully complete the development of new products and produce them economically, secure intellectual property positions including valid and enforceable patent and trademark rights, execute agreements required to successfully advance the company's objectives, retain the scientific management team to advance the products, obtain additional funding as and if needed, adverse changes in market conditions and the regulatory environment, fluctuations in sales volumes, and realization of intangible assets. Furthermore, APNB does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this news release should be considered in conjunction with the warnings and cautionary statements contained in APNB's recent filings with the SEC.

AspenBio Pharma, Inc.
http://www.aspenbiopharma.com

Potential Linkages Between Two Serious Problems Facing The Elderly Examined

2007-04-15T20:39:00.001-07:00

Dementia, including Alzheimer's disease, is one of the most devastating conditions of older age. Currently affecting nearly 7 million individuals in the U.S. and 24 million worldwide, dementia leads to total loss of memory and the ability to function independently - making it one of people's greatest fears of aging.

Delirium is an acute confusional state, a common and serious complication in older individuals that often follows surgery or serious illness. Sometimes accompanied by disorientation, paranoia and hallucinations, delirium develops in 14 to 56 percent of all hospitalized seniors, complicating hospital stays for over 4 million older individuals in the U.S. each year.

For the most part, dementia and delirium have been viewed as separate and distinct conditions. But a special section of The Journal of Gerontology: Medical Sciences, appearing in January 2007, looks at their interface, asking: Can delirium itself lead to the development of a cognitive disorder? Do delirium and dementia represent opposite ends of the same spectrum of disease, rather than two separate conditions?

"I have been studying delirium for 20 years," says Sharon Inouye, MD, MPH, a geriatrician at Beth Israel Deaconess Medical Center and Director of the Aging Brain Center at the Institute for Aging Research, Hebrew SeniorLife. "And the more cases I encounter, the more linkages I see with dementia. For a large proportion of older patients, the problem [of delirium] is never resolved. I routinely hear from patients' families, 'They went into the hospital, they became very confused, and they never recovered.'"

Inouye, a professor of medicine at Harvard Medical School, together with Luigi Ferrucci, MD, PhD, Chief of the Longitudinal Studies Section of the National Institute on Aging and Editor-in-Chief of the journal, which is published by the Gerontological Society of America, examined the relationship between these two widespread conditions during the "Aging Brain Center Scientific Symposium: The Interface of Delirium and Dementia," held last spring.

"Better understanding of delirium may represent a new window of opportunity for the prevention of dementia," explains Ferrucci. "We, therefore, decided to approach the subject from a multidisciplinary perspective, exploring delirium and dementia from a number of vantage points." Findings spawned from the symposium make up the five articles featured in the special issue of the journal, including:

* Biomarkers. "There is currently no way of identifying delirium save for the observations of an astute clinician," notes Inouye. In this review article, BIDMC geriatrician Edward Marcantonio, MD, examines a number of promising biomarkers for delirium, including serum chemistries,genetic markers, serum anticholinergic activity, neurotransmitters, inflammatory markers and cortisol.

* Role of neuroimaging. Physicist David Alsop, PhD, of BIDMC's Department of Radiology, describes major advances in neuroimaging - including advanced methods using magnetic resonance (MR) imaging, positron emission tomography (PET) and single photo emission computed tomography (SPECT) -- which offer the possibility of using highly sensitive imaging techniques to detect changes in the brain following episodes of delirium and thereby investigate the mechanisms and networks involved in its onset and consequences.

* Use of SPECT scanning to assess cerebral perfusion changes in patients with delirium. Led by Tamara Fong, MD, of BIDMC's Department of Neurology, this paper describes the results of a study examining a group of hospitalized patients, which shows that frontal or parietal cerebral perfusion abnormalities occur in cases of delirium. These results suggest localized involvement in the brain's frontal and parietal lobes with delirium, which may correlate with the clinical findings and long-term outcomes.

* The link between anesthesia and development of long-term delirium. Zhongcong Xie, MD, together with senior author Rudolph Tanzi, MD, of the Genetics and Aging Research Unit, Massachusetts General Institute for Neurodegenerative Disease, demonstrate that the commonly used anesthetic isoflurane results in neuronal cell death, and enhancement of A-beta oligomerization, for the first time, providing a direct link between the acute effects of inhalational anesthetics (recognized risk factors for delirium) and the hallmark mechanisms of Alzheimer's disease neuropathogenesis.

* The potential role for cognitive reserve. Inouye, together with BIDMC gerontologist Richard Jones, ScD, an investigator in the Institute for Aging Research at Hebrew SeniorLife, report their findings showing that hospitalized older persons with lower levels of education may be at increased risk for delirium relative to older persons with more education. "People have varying degrees of cognitive reserve, the capability to withstand insults and stresses to their system [such as might occur in a hospital setting]," explains Inouye. "Our study shows that amount of education correlates with brain resiliency, perhaps by building greater numbers of neuronal pathways."

Delirium is a tremendous expense to the country's medical system, amounting to more than $7 billion per year in hospital expenses and more than $100 billion a year when rehabilitation, institutionalization and long-term care is factored in.

In a 1999 study in The New England Journal of Medicine, Inouye demonstrated that delirium can be decreased by 40 percent by implementing a number of straightforward interventions while patients are hospitalized. These include making sure that patients are oriented and hydrated, that they are up and walking, that they are using their hearing aids and vision aids, and that they avoid the use of sleep medications.

"Our goal now is to better understand the fundamental changes that cause delirium and determine whether they result in permanent injury to the brain, in order to better devise ways to intervene and prevent this injury," explains Inouye. "Knowing that our population is rapidly aging, these figures are only going to increase unless we do something now. We hope to eventually be able to identify at-risk individuals before they develop delirium, so that we can intervene before it escalates to a chronic condition."

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In addition to Inouye, coauthors include: BIDMC investigators Edward Marcantonio, MD, and David Alsop, PhD, and Brigham and Women's Hospital investigators James Rudolph, MD, Deborah Culley, MD, and Gregory Crosby, MD, for "Serum Biomarkers for Delirium."

David Alsop, Michael Fearing, PhD, of Hebrew SeniorLife, Keith Johnson, MD, of Massachusetts General Hospital, Reisa Sperling, MD, of Brigham and Women's Hospital, and Tamara Fong, MD, of BIDMC for "The Role of Neuroimaging in Elucidating Delirium Pathophysiology."

Tamara Fong, MD, Sidney Bogardus, Jr., MD, Linda Leo-Summers, Aditya Daftary, MD, and Hal Blumenfeld, MD, and John Seibyl, MD, of Yale University School of Medicine; Eliza Auerbach, MD, of Columbia School of Medicine; Sharada Modur of Ohio State University, for "Cerebral Perfusion Changes in Older Delirious Patients Using 99mTc HMPAO SPECT."

Zhongcong Xie, PhD, Yuanlin Dong, Uta Maeda, Robert Moir, and Rudolph Tanzi, PhD, of Mass General Institute for Neurodegenerative Disease, MGH; Deborah Culley, MD, and Gregory Crosby, MD, of Brigham and Women's Hospital for "Isofluorane-Induced Apoptosis: A Potential Pathogenic Link Between Delirium and Dementia."

Richard Jones, ScD, Frances Yang, PhD, Ying Zhang, MD, MPH, Dan Kiely, MPH, MA, and Edward Marcantonio, MD, of the Institute for Aging Research, Hebrew SeniorLife for "Does Educational Attainment Contribute to Risk for Delirium? A Potential Role for Cognitive Reserve."

Funding for the studies and article was provided, in part, by grants from the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health, the Alzheimer's Association and the Donaghue Medical Research Foundation.

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and ranks third among independent hospitals nationwide in National Institutes of Health (NIH) funding. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.harvard.edu/.

The Aging Brain Center is housed within Hebrew SeniorLife's Institute for Aging Research, the country's largest geriatric research facility in an applied setting. It is located at Hebrew Rehabilitation Center in Boston, which is also a major teaching site for the Harvard Medical School Multi-Campus Fellowship in Geriatric Medicine. IFAR is distinguished by the multidisciplinary nature of its faculty, which includes both social and medical research scientists.

Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center

Low-Dose Aspirin Lowers Risk Of Asthma Diagnosis

2007-04-15T20:35:00.001-07:00

In a large, randomized, placebo-controlled study of 22,071 healthy male physicians, taking a low-dose of aspirin every other day lowered the risk of receiving an initial asthma diagnosis by 22 percent.

These findings, based on data from the double-blind Physicians' Health Study, appear in the second issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Tobias Kurth, M.D., Sc.D., of the Division of Aging at Brigham and Women's Hospital in Massachusetts, and five associates studied physicians, ages 40 to 84, over a period of 4.9 years. Among the 11,037 individuals who took aspirin, 113 new cases of asthma were diagnosed, as contrasted to 145 in the placebo group.

Asthma is a chronic inflammatory disease that causes potentially reversible obstructive lung problems. Breathing difficulties from asthma usually occur during "attacks," which involve narrowing of the airways, swelling of the lining, tightening of respiratory muscles and an increased secretion of mucus. In 2004, more than 20 million Americans were estimated to have asthma.

"Aspirin reduced the risk by 22 percent of newly-diagnosed adult-onset asthma," said Dr. Kurth. "These results suggest that aspirin may reduce the development of asthma in adults. They do not imply that aspirin improves symptoms in patients with asthma."

"Indeed, asthma can cause severe bronchospasm in some patients who have asthma," he continued. "Because asthma was not the primary endpoint of the U. S. Public Health Service study, additional randomized trials would be helpful to confirm the apparent reduction in asthma incidence caused by aspirin."

The Physicians Health Study, which began in 1982, was terminated after 4.9 years when results showed a 44-percent reduction in the risk of a first heart attack among those randomly assigned to aspirin.

"Physicians could self-report an asthma diagnosis on questionnaires at baseline, at six months and annually thereafter," said Dr. Kurth. "Asthma was not the original deductive endpoint of the trial."

According to the authors, the 22-percent lower risk of newly-diagnosed asthma among those assigned to the low-dose aspirin group was not affected by participant characteristics like smoking, body mass index or age.

They noted that aspirin-intolerant asthma, a problem in which aspirin exacerbates the disease, affects only a small minority of asthma patients. In three large population-based studies, that difficulty affected only four to 11 percent of the groups. In children, however, the proportion affected by aspirin intolerant asthma was significantly smaller.

###

Contact: Suzy Martin
American Thoracic Society

Narcotics Often Prescribed For Back Pain But Efficacy Data Are Poor And Chances For Abuse High

2007-04-15T19:38:00.001-07:00

A review of studies on use of narcotics for chronic back pain found that they are commonly prescribed and may help for short-term pain relief but that substance abuse disorders are common, occurring in up to 24 percent of cases (Review, p. 116). But many of the studies are of poor quality and none evaluated relief of pain lasting 16 weeks or longer.

###

Tip sheet: Annals of Internal Medicine, Jan. 16, 2007, issue

NOTE: Annals of Internal Medicine is published by the American College of Physicians.

Contact: Susan Anderson
American College of Physicians

Big Purses Can Cause Big Problems To Your Health

2007-04-15T19:35:00.001-07:00

Was a big purse on your wish list this holiday season? It's one of the biggest fashion trends this season, but experts say those over-sized bags may leave you with back, neck and shoulder pain, headaches and possibly even arthritis.

"I see so many women with neck pains and headaches and what I usually do is look for their purse and pick it up," says Jane Sadler, M.D., family practice physician on the medical staff at Baylor Medical Center at Garland.

"We take it over to the scale and weigh it and usually they're anywhere from 7 to 10 pounds."

The new extra-large purses mean women are carrying more, causing an imbalance as they walk and stand.

"If you think about how you carry a bag, it's usually on one side and you kind of pull your neck to one side and lift your shoulder. It's a very unnatural position," says Dr. Sadler.

That kind of weight pulling down on you for several hours at a time can leave a lasting impression.

"It creates strain along the neck and into the nerves that exit the neck and down the shoulder so it can be very painful later on for many women," adds Dr. Sadler.

So how heavy is too heavy when it comes to your purse? Dr. Sadler says that if you're carrying your cell phone, makeup and wallet in your purse that's already too much. If your purse is uncomfortable when you put it on, if you can feel it pulling on your shoulder, or if it weighs more than just a few pounds, Dr. Sadler says it may be time to downsize your bag.

"We're really going to see women with more and more problems later on if we continue the big purse craze," Dr. Sadler says.

Here's a couple of tips to help you lighten your purse load: try downsizing your wallet only carry the credit cards and cash you need, leave the oversized makeup bags at home, and carry your cell phone with a clip on your body.

For more information about Baylor Medical Center at Garland, visit http://www.BaylorHealth.com.

Baylor Health Care System
2001 Bryan St., Ste. 2200
Dallas, TX 75201
United States
http://www.BaylorHealth.com

Anesiva Announces Clinical Data From Phase 1 Trial Of 1207

2007-04-15T18:39:00.001-07:00

Anesiva, Inc. (Nasdaq: ANSV) announced today clinical data from a Phase 1 safety study of product candidate 1207, which was being tested as a topical anesthetic for treatment of neuropathic patients. 1207 achieved the primary endpoint of the study of safety and tolerability. In the studied population of healthy volunteers, no clear anesthetic effect of 1207 was demonstrated.

"While we are disappointed that we did not see positive efficacy in this trial, our primary focus is on our two most advanced pain product candidates -- Zingo(TM), for which we recently filed a New Drug Application, and 4975, which is expected to enter pivotal trials later this year," stated John P. McLaughlin, chief executive officer of Anesiva. "Based on the results of the Phase 1 trial of 1207, we are no longer pursuing the clinical development of this drug."

The Phase 1 study enrolled a total of 24 adult healthy male volunteers in six dose-escalating cohorts at a single clinical center in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study measured sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been submitted for the most advanced product, Zingo(TM). The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com/.

Forward Looking Statements

This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended September 30, 2006.

Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

Anesiva, Inc.
http://www.anesiva.com/

Penwest Begins Next Study In Development Of Nalbuphine ER

2007-04-15T18:36:00.001-07:00

Penwest Pharmaceuticals Co. (Nasdaq: PPCO) today announced that it has begun a Phase I safety study on a nalbuphine hydrochloride extended release tablet formulation (Nalbuphine ER) that the Company is developing for the treatment of pain.

Nalbuphine ER is a controlled release formulation of nalbuphine hydrochloride that Penwest is developing using its TIMERx(R) drug delivery technology. It is designed to be taken as a twice-daily tablet.

The primary objective of the Phase I safety study is to evaluate the safety and tolerability of the drug in healthy subjects of escalating dosage levels during multiple-dose steady-state administration. The secondary objective is to evaluate the pharmacokinetics of nalbuphine during steady-state administration and the effect of different nalbuphine ER dosage levels on typical opioid-related side effects.

Alan F. Joslyn, Ph.D., Penwest's Senior Vice President of Research and Development, said, "This next step in the clinical development of nalbuphine ER demonstrates our progress in building our own product portfolio. We are conducting the Phase I safety study to enhance our understanding of the safety and pharmacokinetics of multiple doses of nalbuphine ER over the projected clinical dose range. We believe that, combined with the single dose safety and efficacy data we already have, this study will give us the information necessary to advance to the Phase II program we intend to begin in the first half of this year."

The study will employ a randomized sequential dose-escalation design, with a planned total enrollment of 32 healthy adult subjects in two separate alternating cohorts. The study will examine a total of four dosage levels. Each subject will receive treatment at two different dose levels sequentially, with a number of days at each dosage level until steady state plasma concentrations are achieved.

The Company expects subject participation to be complete by the end of February, with data available in the second quarter.

About Penwest

Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The Company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for diseases of the nervous system. At the core of this strategy, Penwest applies drug delivery technologies, including its own proprietary technologies, to new and existing compounds to enhance their therapeutic profiles. The launch by Endo Pharmaceuticals of Opana(R) ER (oxymorphone hydrochloride extended-release tablets) in mid-2006 demonstrates the execution of this strategy and the value of Penwest's TIMERx(R) extended release delivery technology. Penwest is currently applying its expertise to a pipeline of potential products that are in various stages of development. The Company intends to commercialize these products independently and through third party alliances.

Forward-Looking Statement

The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause Penwest's actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," "potential," and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include: risks relating to the commercial success of our products; regulatory risks relating to drugs in development, including the timing and outcome of regulatory action; uncertainty of success of collaborations; the timing of clinical trials and whether the results of clinical trials will warrant further clinical trials or warrant submission of an application for regulatory approval of, or the regulatory approval of, the product that is the subject of the trial; actual and potential competition; the need for capital; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2006, which risk factors are incorporated herein by reference.

The forward-looking statements contained in this press release speak only as of the date of the statement made. Penwest disclaims any intention or obligation to update any forward-looking statements.

TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.

Penwest Pharmaceuticals Co.
http://www.penw.com/

Pharmos Announces Clinical Data From Phase 2a Trial Of Cannabinor For Capsaicin-induced Pain

2007-04-15T17:39:00.001-07:00

Long-Term Narcotics Use For Back Pain May Be Ineffective And Lead To Abuse

2007-04-15T17:35:00.001-07:00

Childhood Obesity Linked To Foot Pain

2007-04-15T16:39:00.001-07:00

Leading Radiofrequency Manufacturer Introduces A New Product For Treating Heel Pain

2007-04-15T16:35:00.001-07:00

Installation Of A Second Neuroscope(TM) For Gastroenterology Research

2007-04-15T15:38:00.001-07:00

Medifit Instruments Limited, the world leading company in the measurement of Cardiac Vagal Tone and non-invasive Brainstem Assessment, announces the successful installation of a second Neuroscope(TM) for gastroenterology research at Hope Hospital, Salford, UK.

The Neuroscope is being successfully used in studies leading to the identification of mechanisms for the future management of pain.

Professor Qasim Aziz and clinical research fellow Dr. Peter Paine were so impressed with the results obtained from the first NeuroScope that a second was soon commissioned. In commenting, Dr. Peter Paine described the information derived from the use of the Neuroscope as being of the highest quality and extremely beneficial and cost effective to our research. He added, It is simply "essential to our work - we are so convinced as to the benefits of the Neuroscope that we are ordering a third device".

Medifit Instruments Limited, based in London at Enfield, UK, manufactures and Markets the Neuroscope(TM), which is the only diagnostic device capable of assessing Cardiac Vagal Tone, non-invasively and in real time. As part of the Central Medical Processor - as a tele-medicine vital signs platform - it is a world leader in the integration and management of patient vital signs and the assessment of brainstem function.

In clinical settings the Central Medical Processor enables the physician to view the patient as a virtual bulletin board of vital signs; the actions and reactions of the brainstem in real time are displayed on a beat by beat (heart beat) basis to provide an instant assessment of how the brain is reacting to any given circumstance.

More information from the company - telephone 079 399 36419 (+44 79 339 36419 if calling from outside the UK)

Empowering Medical Practitioners through improved Diagnostics

Medifit Instruments Limited
Innova Business Centre
Electric Avenue
Enfield
EN3 7XU
ENGLAND
Registered in England, number 3895663
VAT: GB749 4057 07
Phone: +44 (0) 20 8344 8545
Fax: +44 (0) 20 8350 1351
info@medifitinstruments.com
www.medifitinstruments.com

Aspirin Saves Lives Of Cancer Patients Suffering Heart Attacks, Despite Fears Of Bleeding

2007-04-15T15:35:00.001-07:00

Many cancer patients who have heart attacks often are not treated with life saving aspirin given the belief in the medical community that they could experience lethal bleeding. Researchers at The University of Texas M. D. Anderson Cancer Center, however, say that notion is now proven wrong and that without aspirin, the majority of these patients will die.

Researchers say that their study, to be published in the February 1, 2007 issue of the journal Cancer and now available online, turns common medical assumptions upside down and will likely change medical practice for cancer patients. Because aspirin can thin blood and cancer patients experience low platelet counts and abnormal clotting, physicians view aspirin as a relative contraindication. Given that blood platelets are responsible for the clotting process, physicians do not eagerly prescribe aspirin as a standard treatment.

In this study, however, the investigators found that 9 of 10 cancer patients with thrombocytopenia (low platelet count) who were experiencing a heart attack and who did not receive aspirin died, whereas only one patient died in a group of 17 similar cancer patients who received aspirin. They also found aspirin helps cancer patients with normal platelet count survive heart attacks, just as it does for people without cancer.

"The notion that heart attacks in patients with low platelets should be treated with clot-dissolving aspirin defies logic, that is unless you suspect that the cancer is interfering with platelet function," says the study's senior investigator and author, Jean-Bernard Durand, M.D., assistant professor in the Department of Cardiology at M. D. Anderson Cancer Center.

"We believe tumors may be releasing chemicals that allow the cancer to form new blood supplies which makes blood more susceptible to forming clots." Durand, a heart failure specialist, says. "There appears to be a platelet paradox suggesting that cancer may affect the mechanism of the way that blood clots, and from this analysis, we have found that the single most important predictor of survival in these patients is whether or not they received aspirin." Durand says more research is needed to better understand this contraindication.

According to the World Health Organization there are approximately 10 million cancer patients worldwide, of which 1.5 million may develop blood clots during their cancer treatment and, as such, are at a much higher risk of dying from heart disease if not treated properly. "Now that we have this study, it would be a travesty if you survive treatment for cancer only to die of a heart attack soon thereafter," Durand says.

According to Durand, no guidelines currently exist for treatment of heart attacks in patients with cancer. He says that physicians are especially perplexed about what to do for cancer patients with thrombosis (blood clots), a condition that affects about 15 percent of all cancer patients and can be due to the use of chemotherapy or the presence of cancer.

Durand came to M. D. Anderson in 2000 to start the Cardiomyopathy Services, which is believed to be the only program in the world specifically designed to look at cardiovascular complications caused by chemotherapy treatment. He is also the co-founder of CONQUER (Cardiology Oncology International Quest to Educate and Research Heart Failure in Cancer), a newly created organization with goals of increasing the success of chemotherapy by reducing cardiovascular disease as a barrier and long term risk.

He and anesthesiologist Mona Sarkiss, M.D., Ph.D., made the observation that patients with thrombocytopenia who suffered a heart attack and were being treated in the intensive care unit at M. D. Anderson tended to die more often when they were not given aspirin. However, they noted that some of the patients given aspirin and/or beta-blockers had "great" clinical outcomes. "Because no practice guidelines exist, physicians were treating their patients with great variability and the disparity was obvious," Durand says.

Sarkiss, who is the study's lead author, Durand, and a team of researchers which included investigators from Baylor College of Medicine and Duke University Medical Center, conducted a retrospective analysis of cancer patients treated for heart attacks at M. D. Anderson Cancer Center in 2001. These 70 patients were divided into two groups based on their platelet counts, and data was collected on the use of aspirin, bleeding complications, and survival.

They found that heart attack patients with low platelets who did not receive aspirin had a seven-day survival rate of 6 percent, compared with 90 percent survival in those who received aspirin. Dr. Durand notes that there were no severe bleeding complications in patients who used aspirin. Conversely, patients with low platelet counts who formed a blood clot and were not exposed to aspirin died.

The beneficial effect of aspirin also was seen in patients with normal platelet counts. Seven-day survival was 88 percent in aspirin-treated patients as compared to 45 percent in patients who did not receive aspirin, the researchers found.

Durand observed that these deaths rates are abnormally high. "In the non-cancer patient with acute coronary syndrome anywhere in the United States, an expected seven-day mortality is less than 1 percent," he says.

There were parallel findings for those patients in either group who were treated with beta-blockers, which block the heart's use of adrenalin. The protective effect was not as strong as seen with aspirin, but was still life saving.

In those patients with a normal platelet count, 91 percent survived seven days when treated with beta-blockers, whereas 36 percent survived if they were not treated with the agent. In the thrombocytopenic group, 73 percent survived seven days when treated with beta-blockers, whereas only 13 percent survived if they were not treated.

###

Investigators working with Durand and Sarkiss were: Andrew Shaw, M.D., from Duke; Nasser Lakkis, M.D. from Baylor; and S. Wamique Yusuf, M.D., Carla Warneke, M.D., Gregory Botz, M.D., Cheryl Hirsch-Ginsburg, M.D., J. Chris Champion, M.D., Joseph Swafford, M.D., and Daniel Lenihan, M.D., from M. D. Anderson.

Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center

Potential New Pain Therapy Target Revealed By Scripps Research Study

2007-04-15T14:39:00.001-07:00

The study was published January 21, 2007 in an advanced online edition of the journal Nature.

The researchers found that TRPA1, a protein that helps transmit pain signals, is a direct sensor of reactive chemicals. "While many noxious and pungent compounds were known to activate this pain receptor, we discovered that they do so by directly and irreversibly binding to the cysteine amino acids of this protein," said Ardem Patapoutian, a Scripps Research scientist whose laboratory conducted the study. "Our study shows that TRPA1 activation is directly linked to chemical insult."

"Cysteines, one of the twenty building blocks of all proteins, are known to undergo oxidation/reduction reactions," Patapoutian continued. "Somehow the TRPA1 protein is tuned to sense cysteine modifications. In fact, any cysteine reactive agent seems to activate TRPA1, although we don't know exactly how cysteine binding translates into ion channel activation."

But this activation mechanism comes with an interesting property.

"Generally, compounds that activate ion channels bind in a lock-and-key mechanism that is readily reversible," said Lindsey Macpherson, another author of the study and a Ph.D. candidate in the Scripps Research Kellogg School of Science and Technology. "The mechanism by which noxious compounds activate TRPA1 is unique. For example, compounds that activate an ion channels through a lock-and-key mechanism have structural similarity. TRPA1 activators have no structural similarity; instead, they share a common potential for chemical reactivity, and their binding is long-lasting."

TRPA1 is not unique among proteins to be activated by cysteine modifying agents, the study noted. Another signaling protein known as Kelch-like ECH-associated protein 1 (KEAP1) is activated by many of the same compounds that activate TRPA1; KEAP1 is a sensor for oxidative damage from free radicals and upregulates expression of antioxidant enzymes. Apparently, reactive compounds can activate at least two pathways through cysteine modification as a warning against cell damage, the study concluded.

"Our findings, which are the result of a successful collaboration with the Ben Cravatt and Peter Schultz labs at Scripps Research, show that modification of reactive cysteines within TRPA1 can cause channel activation," Macpherson said. "Our research efforts are now aimed at further understanding how binding of these compounds activate the channel, and identifying the physiological role of TRPA1 in sensing oxidative stress." The protein is currently being investigated by several pharmaceutical companies as a potential target for chronic pain, Patapoutian noted.

###

Other authors of the study, Noxious Compounds Activate TRPA1 Ion Channels Through Covalent Modification Of Cysteines, are Adrienne E. Dubin, Michael J. Evans, Felix Marr, and Benjamin F. Cravatt of The Scripps Research Institute; and Peter G. Schultz of The Scripps Research Institute and Genomics Institute of the Novartis Research Foundation.

The study was supported by the National Institutes of Health and the Novartis Research Foundation.

About The Scripps Research Institute

The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.

Contact: Keith McKeown
Scripps Research Institute

AAGBI Response To The BMJ Medical Milestones Poll Results

2007-04-15T14:36:00.001-07:00

The Association of Anaesthetists of Great Britain and Ireland is pleased to note the results of the British Medical Journal Medical Milestones Poll to find the most important medical advance since the BMJ started in 1840.

вЂЁвЂЁThe most important advance was Sanitation, [clean water and sewage disposal] followed by Antibiotics, and then Anaesthesia in third position, within two percentage points of the winner.

вЂЁвЂЁCongratulations to Sanitation, in which John Snow (an anesthetist) was also involved, and the important advance of Antibiotics.

вЂЁвЂЁDr David Whitaker, President of the Association comments, "for Anaesthesia to be ranked in the top three out of an original list of 70 is significant recognition for the importance of the work Anaesthetists do caring for patients through our particular specialty".

вЂЁвЂЁSuch acknowledgement of Anaesthesia also provides a pleasing start to the Association of Anaesthetists of Great Britain and Ireland's 75th Anniversary Year.

вЂЁвЂЁThe AAGBI was originally set up in 1932, "to develop Anaesthesia" into what has successfully become the very important specialty further recognized today.

вЂЁвЂЁAssociation of Anaesthetists Anniversary strapline is "75 years, advancing patient safety", which underlines the improvements in patient care and mortality that have continued since the original milestone.

Association of Anaesthetists of Great Britain and Ireland

Scientific, Medical Luminaries Gather At New York Symposium To Discuss The Science Of Electroceuticals

2007-04-15T13:39:00.001-07:00

An impressive lineup of medical researchers and clinicians, including Nobel Laureate Louis Ignarro, PhD, gathered at a December 19 symposium in New York City to discuss the new and important scientific discipline of Electroceuticals. В В The next frontier in pulsed electromagnetic field (PEMF) therapy and electrotherapeutics, Electroceuticals are highly-refined electromagnetic fields that are now being used to non-invasively "jumpstart" the body's natural anti-inflammatory response to treat pain successfully and help soft tissue wounds heal faster.В

В Speakers discussed how advances in physics, biology and engineering have all begun to allow medical clinicians to directly affect the electrochemical processes that control all biological processes.В The complete proceedings, which are summarized below, can be accessed at http://www.ivivitechnologies.com.

В В "The science of Electroceuticals is so rich; it is always thrilling to bring such incredible minds together to discuss this exciting field," said Andre DiMino, founder and Co-CEO of Ivivi Technologies, Inc., a company dedicated to the field of electrotherapeutics and sponsor of the symposium.

В DiMino introduced the symposium line-up.В Some key presenters and panelists included:

В Arthur Pilla, PhD., the original developer of bone growth stimulation technology and a leading authority on bioelectromagnetic responses in therapeutic medical applications provided a "state of the science" and discussed the creation and identification of electrotherapeutic signals.В

В Pilla, a professor of biomedical engineering at Columbia University, said that applications for which Electroceuticals are already known to be effective include the healing of recalcitrant bone fractures, increasing the success rate of spinal fusion from 50% to 85%, healing chronic and acute soft tissue wounds, suppressing the body's inflammatory response, increasing local blood circulation, and perhaps most exciting, encouraging angiogenesis.

В Pilla also discussed the practical effects of electrotheraputic technologies вЂ" namely reducing costs of healthcare by reducing surgery and morbidity.В In 1980, bone growth stimulators reduced the cost of health care for delayed union fractures by tenfold. In fact, recent studies have shown Electroceuticals' tremendous promise to significantly reduce healing time, including 59% on surgical wounds, 69% on tendons and 70% on chronic wounds, such as diabetic foot ulcers. В

В Pilla then took attendees across the evolution of the technology to today's Electroceuticals which activate the Calcium(Ca)-Calmodulin(CaM)-Nitric Oxide(NO) pathways that are at the core of the body's healing cascade.

В Louis Ignarro, PhD., who received the 1998 Nobel Prize in Medicine and Physiology for his seminal work on the biological importance of nitric oxide, gave a presentation on the link between Nitric Oxide (NO) and the biological cascade stimulated by the application of Electroceuticals.

В Ignarro, a professor of pharmacology at UCLA, began by discussing the discovery of biological importance of NO, its pharmacological uses, and his discovery that arteries produce NO that maintains the health of the vasculature.В One well-known outcome is the discovery that NO was the neurotransmitter that stimulated male erections, leading to the development of Viagra.В

В Ignarro's research has discovered that NO has a multitude of functions in the body, helping to regulate processes that include angiogenesis, blood pressure control, digestion, respiration and promotion of learning and memory.В NO, found naturally in the human body, is potentially analgesic, anti-oxidant and anti-inflammatory, depending on the biological circumstances.

В Dr. Ignarro described how Ca/CaM activates the enzymes responsible for healthy NO production, the precise binding mechanism triggered by Electroceuticals.В

В Diana Casper, PhD., is a neurobiologist at the Albert Einstein School of Medicine, specializing in neurodegeneration.В She runs the neurosurgery lab at the Montefiore Medical Center. В В

В Casper gave a short history of Parkinson's disease, including pathology and treatments.В She highlighted a 2003 study that determined Parkinson's may be related to inflammation of brain cells, which lasts until death.В Having learned about the effects of pulsed electromagnetic fields, Casper became interested in the possibility that PEMF may help increase neuronal survival in response to inflammation.

В While Casper's research is ongoing, she showed preliminary data which demonstrated the promise of PEMF on neurodegenerative diseases.В Cultures treated with PEMF demonstrated improved neuronal survival.В She also presented data demonstrating decreases in acute inflammation after brain trauma, potentially promising work for problems of inflammation associate with brain trauma.В In a third study, Casper's lab demonstrated that PEMF increases NO levels, which, in turn, has neuroprotective properties.В

В Casper proposed next steps involve animal studies using models of neurodegenerative diseases.В Among the possible neuronal applications for PEMF treatments are Parkinson's, Alzheimer's, Huntington's disease.

В In addition to the keynote speakers, attendees and panelists included several practicing clinicians who described their successful experiences using Electroceuticals to treat patients.В One clinician described his ongoing study of the effect of Electroceuticals on heart disease, based on the known effects of Electroceuticals in improving angiogenesis.

В To access the complete Symposium proceedings please log on to http://www.ivivitechnolgies.com.

В About Ivivi Technologies:

Ivivi Technologies, Inc. (AMEX: II) is a medical technology company focusing on designing, developing and commercializing its proprietary electrotherapeutic technology platform.В Ivivi's research and development activities are focused specifically on pulsed electromagnetic field, or PEMF, technology, which, by creating a therapeutic electrical current in injured soft tissue, stimulates biochemical and physiological healing processes to help repair the injured tissue and reduce related pain and inflammation.В Since the mid-1990's, the Company's Electroceuticals™ have been used for a wide array of conditions, including chronic wounds, pain and edema following plastic and reconstructive surgery and chronic inflammatory disorders.

В Forward-Looking Statements:

This press release contains "forward looking statements" that are subject to risk and uncertainties, including, but not limited to, the Company's limited operating history, history of significant and continued operating losses and substantial accumulated earnings deficit, difficulties with its financial accounting controls, the failure of the market for the Company's products to continue to develop, the inability for customers to receive third party reimbursement, the inability to obtain additional capital, the inability to protect the Company's intellectual property, the loss of any executive officers or key personnel or consultants, competition, changes in the regulatory landscape or the imposition of regulations that affect the Company's products and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's registration statement on Form SB-2.В These risks could cause actual results to differ materially from those expressed in any forward looking statements made by, or on behalf of, the Company.В The Company assumes no obligation to update the information contained in this press release.

Dental Researchers Test No-Needle Anesthesia, No-Drilling Cavity Care

2007-04-15T13:36:00.001-07:00

Imagine having a decayed tooth repaired, painlessly, without drilling or shots of anesthesia to numb the area.

Wishful thinking? Not if two studies being conducted at the University at Buffalo's School of Dental Medicine show positive results.

In one study, funded by a $100,000 grant by Apollonia, LLC, researchers in the school's Center for Dental Studies are testing a nasal spray that numbs the upper teeth.

"If this study is successful," said Sebastian Ciancio, D.D.S., principal investigator on the study, "it may mean the end of dental injections when dentists are performing procedures on the upper arch."

The second study, set to begin in coming months, will test the use of ozone to kill bacteria in a decayed tooth and its potential to eliminate the need for the dreaded drill, at least to repair simple cavities. Researchers at UB and two other U.S. dental schools will conduct the research, which is funded by a $1.5 million grant from Curozone, Inc. and Kavo Dental Manufacturing Co. UB's portion is $400,000.

Ciancio, who also is the UB principal investigator on this study, said the ozone delivery device currently is being used in Europe. "If the U.S. studies are successful, it should be available in this country in about two years," he said.

The nasal spray study is testing the effectiveness in dental procedures of a topical anesthetic normally used by ear, nose and throat physicians when they operate on the nose. Patients who received this anesthetic for that purpose reported it also numbed their upper teeth, sparking interest in using it for dental procedures.

"We currently are testing to determine what the optimal dose is for this spray when used as an anesthetic agent for the maxillary (upper) teeth," said Ciancio. "The current study includes 85 patients and should be completed by the end of January and will be followed by a second study in March. Once we know the results, we'll then test it in a broader population."

Co-investigators, all from the UB dental school, are Eugene Pantera, D.D.S., Sandra Shostad, D.D.S., and Joseph Bonavilla, D.D.S.

The ozone study will evaluate the effectiveness of the ozone delivery device, which fits over a tooth and forms an airtight seal, in arresting tooth decay. The study will enroll 125 participants and will last 18 months.

"Following application of the ozone, patients will use a remineralizing solution, which strengthens the weakened tooth structure and, in many cases, eliminates the need for any dental drilling," said Ciancio.

Additional investigators on this study are Othman Shibly, D.D.S., Jude Fabiano, D.D.S., Benita Sobieroj, D.D.S., Maureen Donley, D.D.S., and Nina Kim, D.D.S., all from the UB dental school faculty.

Contact: Lois Baker
University at Buffalo

Low-Dose Steroids Reduce Joint Damage From Rheumatoid Arthritis

2007-04-15T12:39:00.001-07:00

Low doses of steroids can inhibit joint damage when used in the early phase of rheumatoid arthritis, according to a new review of evidence.

High-quality evidence supports combining the pills with standard medications in the first two years after diagnosis. "Such treatment should be made readily available to patients," say review authors led by John Kirwan of Liverpool Women's Hospital in England.

Concern exists about the side effects of steroid therapy, however. High doses can contribute to heart disease, osteoporosis and other complications. Questions remain about whether smaller doses lead to similar problems.

Rheumatoid arthritis is a chronic disease in which the body's immune system attacks and destroys healthy joint tissue. The hands and feet are frequently affected, and as the disease progresses it can cause pain, swelling, deformity and disability.

The steroids studied in the review are known as glucocorticoids and include the well-known anti-inflammatory prednisone. This medication is often prescribed in the first few months after diagnosis to relieve the discomfort of RA until slower-acting drugs begin protecting the joints.

Until now, concerns about side effects caused most rheumatologists to "put people on the lowest possible dose of steroids and get them off it as soon as possible," said Scott Zashin, M.D., of the University of Texas Southwestern Medical Center. "Now, we have to give steroids a little more respect."

The review appears in the most recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

The systematic review is based on 15 studies including 1,414 patients. In most of the studies, patients received low doses of glucocorticoid pills along with so-called disease-modifying drugs for one to two years. Periodic X-rays revealed the extent of joint erosion and other signs of damage.

All studies except one showed reduced progression of joint damage in patients taking glucocorticoids. When reviewers used statistical methods to focus on only the highest-quality data, the benefits remained statistically significant.

"Even in the most conservative estimate, the evidence that glucocorticoids given in addition to standard therapy can substantially reduce the rate of erosion progression in rheumatoid arthritis is convincing," they say.

The authors say, however, that minimization of joint damage seen on X-rays may not equate to noticeable improvements for patients: "It does not necessarily follow that patients will gain long-term functional benefit." However, two related studies, including one by Kirwan, suggest "an important link" between the two.

Because of the known health risks associated with intensive steroid use, concern persists regarding long-term use at any level. The authors cite a 2006 systematic review covering the adverse effects of low-dose glucocorticoids, which concluded that "few of the commonly held beliefs about their incidence, prevalence and impact are supported by clear scientific evidence."

Moreover, safety data from recent randomized controlled clinical trials of low-dose steroids for RA suggest that negative side effects are "modest" and similar to those of sham treatments, say Kirwan and colleagues. Additionally, the most immediate concern -- reduced bone mineral density -- can now be readily treated.

Nevertheless, potential adverse reactions to glucocorticoid therapy merit further research, say the authors, as does usefulness of steroid treatment for patients who have had rheumatoid arthritis for 3 years or more.

Zashin urges patients recently diagnosed with rheumatoid arthritis to see a rheumatologist without delay. Early and aggressive treatment can prevent severe joint damage and disability for most people, he says.

###

Kirwan JR, et al. Effects of glucocorticoids on radiological progression in rheumatoid arthritis (Review). Cochrane Database of Systematic Reviews 2007, Issue 1.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.

Contact: Lisa Esposito
Center for the Advancement of Health

2 Minutes Conversation prevents RX - Wrong-Site Surgery

2007-04-15T12:35:00.001-07:00

A study of Johns Hopkins surgeons, anesthesiologists and nurses suggests that hospital policies requiring a brief preoperation "team meeting" to make sure surgery is performed on the right patient and the right part of the body could decrease errors.

In the study, which will appear in the February issue of the Journal of the American College of Surgeons, Hopkins OR personnel were "very positive" about the briefings, according to surgeon Martin Makary, M.D., M.P.H., director of the Johns Hopkins Center for Surgical Outcomes Research and lead author of the study.

"Although we lack systems for uniform reporting of wrong-site surgeries to understand the extent of the problem, we observed team meetings increase the awareness of OR personnel with regard to the site and procedure and their perceptions of operating rooms safety" says Makary. He stressed that wrong-site surgery is exceptionally rare but entirely preventable.

A study published last year in the Archives of Surgery that looked at 2.8 million operations in Massachusetts over a 20-year period suggests that the rate of "wrong-site" surgery anywhere other than the spine is 1 in every 112,994 operations. The study excluded the spine because researchers defined wrong-site surgeries as operations conducted on a different organ or body part than intended by the surgeon and patient. Since the spine is one body part, even though a surgeon may have operated on the wrong part of the spine, technically it is still the right part of the body.

The Joint Commission, which evaluates and accredits nearly 15,000 health care organizations and programs in the United States, requires hospitals to have a presurgical conversation in the OR before every surgery.

Although Makary says no national standard was set by the Joint Commission, he and others led efforts at Hopkins to enforce the mandate, developing a standardized OR briefing program that became Hopkins Hospital policy in June 2006. Since then, he has collaborated with Rochester University, Yale, Columbia and Cornell and the World Health Organization to broaden the use and reach of the Hopkins program.

The briefing consists of a two-minute meeting during which all members of the OR team state their name and role, and the lead surgeon identifies and verifies such critical components of the operation as the patient's identity, the surgical site and other patient safety concerns. The briefing is performed after anesthesia is administered and prior to incision.

A survey, among 147 surgeons, 59 anesthesiologists, 187 nurses and 29 other OR staff, was given twice - before implementing the policy and after it had been in effect for three-months.

After training, a 13.2 percent increase in those who believed the policy would be effective was recorded among the OR personnel. And more than 90 percent agreed that "a team discussion before a surgical procedure is important for patient safety."

"The Joint Commission identified communication breakdowns as the most common root cause of wrong-site surgeries," says Makary. "Our research indicates that OR personnel see presurgical briefings as a useful tool to help prevent such errors."

Before the new policy was implemented, Makary notes, many surgeons would walk into the OR and start working without a conversation of any kind and without even knowing the names of the nurses and other staff who were assisting them.

###

The survey is based on a similar questionnaire designed by the airline industry to assess programs designed to reduce safety errors.

Hopkins faculty members Peter J. Pronovost, M.D., Ph.D., and Bryan Sexton, Ph.D., also contributed to the article.

Contact: Eric Vohr
Johns Hopkins Medical Institutions

Back Pain: When To Opt For Surgery, From The Harvard Health Letter

2007-04-15T11:38:00.001-07:00

Low back pain is an extremely common condition: 80% of Americans experience at least one bout of it some time during their lives. Usually, rest, some pain relievers, and perhaps some exercises help it go away. But for many millions, the pain lingers and may become severe and debilitating. How do you know when back pain warrants surgery? The February 2007 issue of the Harvard Health Letter investigates.

Deciding to have surgery is never simple, but it's especially difficult when the back is involved. Many studies of back surgery have been small. Popular procedures have been questioned, and new ones get introduced before we really know how well they'll work over the long haul. It's hard enough for doctors to figure out what to do about surgery for back pain. Patients are often even more confused.

Back surgery is an option for people with long-lasting pain due to herniated disks, spinal stenosis, or degenerative disease. Studies have shown good results from spinal stenosis surgery, with any lingering pain controlled with medication. On the other hand, doctors are beginning to question whether too many surgeries are performed to treat degenerative disease. As for herniated disks, a recent study found that surgical and nonsurgical treatments worked equally well. An editorial accompanying the study said toss-up results show that the decision whether to have surgery is a matter of patient preference more than anything else.

Ideally, your primary care physician can walk you through your options- surgical and non-to get you to an effective treatment.

Harvard Health Publications
http://www.health.harvard.edu/health

Surgical Trauma In Back Surgery Lowered By Pretreating Spinal Cord With Local Anesthetic

2007-04-15T11:35:00.001-07:00

Texas researchers believe that they have discovered how to prevent many cases of the most common problem encountered by patients undergoing spine surgery: failed back surgery syndrome (FBSS).

FBSS occurs when surgery either fails to cure back pain or leads to additional chronic pain after a spinal operation.

In experiments using laboratory rats, neuroscientists at the University of Texas Medical Branch at Galveston (UTMB) applied the local anesthetic Lidocaine to the animals' exposed spinal cords before subjecting the rats to simulated spinal surgery. They found the procedure prevented both the release of chemicals associated with FBSS and behavior typical of animals experiencing FBSS-caused pain.

A paper describing their investigation is in press at the journal Experimental Neurology, and will be available January 26 at the journal's Web site in the "Articles in Press" section.

"Our hypothesis is that the unintentional stretching and compression that can occur in the spinal cord during surgery causes the release of large quantities of chemicals called excitatory amino acids, which produce a toxic environment in the spine and cause long-term hyperexcitability in spinal neurons, generating chronic neuropathic pain - pain produced in the nerves themselves," said UTMB neuroscience and cell biology professor Claire Hulsebosch, a senior author of the paper along with UTMB neuroscience and cell biology professor David J. McAdoo. "When we applied Lidocaine to the surface of the spinal cord before conducting our surgery," Hulsebosch continued, "we found that those releases were completely blocked."

In addition, Hulsebosch noted, rats whose spines had been pretreated with the local anesthetic showed less sensitivity and scored much lower than non-treated rats on a standard test for symptoms of neuropathic pain. In the test, steadily increasing pressure is applied to a rat's hind paws with fishing-line-like filaments. Rats experiencing the hypersensitivity associated with chronic pain tend to withdraw their paws at very low pressures, while those without chronic nerve pain react only to much higher pressures.

Researchers involved in the experiment cautioned that FBSS is a somewhat loose diagnosis, one with multiple causes that also may include pre-existing conditions that spinal surgery does not successfully address. "It also has to be said that the model we used, in which we cut the nerves in the dorsal root on the surface of the spinal cord, involved a severe injury," said UTMB neuroscience graduate student and first author Brian Rooney "But we think it's a good representation of the sort of injury that can be produced by surgery."

###

Neuroscience postdoctoral fellow E.D. Crown also co-authored the paper. The research was supported by grants from the John S. Dunn Research Foundation and the West Endowment, as well as the Frank A. Liddell, Jr. Fund of the Greater Houston Community Foundation, TIRR Foundation's Mission Connect program and the National Institutes of Health.

Contact: Jim Kelly
University of Texas Medical Branch at Galveston

Role Of Anesthetics In Alzheimer's Disease

2007-04-15T10:39:00.001-07:00

Inhaled anesthetics commonly used in surgery are more likely to cause the aggregation of Alzheimer's disease-related plaques in the brain than intravenous anesthetics say University of Pittsburgh School of Medicine researchers in a journal article published in Biochemistry. This is the first report using state-of-the-art nuclear magnetic resonance (NMR) spectroscopic technique to explain the detailed molecular mechanism behind the aggregation of amyloid B (AB) peptide due to various anesthetics.

AB plaques are found in the brains of people with Alzheimer's disease. Many believe that the uncontrolled clumping of AB is the cause of Alzheimer's disease and that the similar aggregation of peptides and proteins play a role in the development of other neurodegenerative diseases such as Parkinson's disease.

"Many people know of or have heard of an elderly person who went into surgery where they received anesthesia and when they woke up they had noticeable memory loss or cognitive dysfunction," said Pravat K. Mandal, Ph.D., assistant professor of psychiatry, University of Pittsburgh School of Medicine and lead author of the study. Previous studies by the Pittsburgh researchers found that the inhaled anesthetics halothane and isoflurane and the intravenous anesthetic propofol encouraged the growth and clumping of AB in a test tube experiment.

"Our prior research had shown in molecular models that anesthetics may play a role by causing amyloid peptides to clump together - something that is thought to signal the advancement of Alzheimer's disease. In this study, we set out to see why this was happening and to determine if any one form of anesthesia might be a safer option than another," said Dr. Mandal.

In this study the researchers used NMR spectroscopy to determine how the inhaled anesthetics halothane and isoflurane and the intravenous anesthetics propofol and thiopental interact with AB influencing the aggregation of AB in forms commonly found in the brains of people with Alzheimer's disease. The results were strikingly different between the inhaled and injected anesthetics. The inhaled halothane and isoflurane had the most potent interaction with AB peptides causing the highest levels of AB aggregation. The injected anesthetic propofol only interacted and caused aggregation at high concentrations - interaction was not evident at lower concentrations. The intravenous thiopental did not cause the clustering of AB peptides even at high concentrations. Additionally, the molecular details for the interaction of these anesthetics with AB peptide were revealed.

Dr. Mandal noted that if the same thing occurs in humans, anesthetics could lead to more amyloid plaques which may lead to earlier memory problems, warranting further studies of anesthetics with AB both in laboratory and clinical settings.

###

The study was partly funded through grants from the American Parkinson Disease Association and American Health Assistance Foundation.

Contact: Jocelyn Uhl Duffy
University of Pittsburgh Medical Center

Empi Announces FDA Clearance Of Select(TM) TENS Device

2007-04-15T10:35:00.001-07:00

Empi, a global market leader in non-invasive, non-systemic pain management and physical rehabilitation for more than 30 years, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance to market the Empi Select(TM) TENS (Transcutaneous Electrical Nerve Stimulation) device.

The Select(TM) device is designed specifically for the relief of chronic, arthritic, and post-surgical pain. The portable device can be used at home or on-the-go, and integrates site specific, preset treatment programs that make it convenient and easy-to-use. This feature ensures that the patient receives the appropriate electrotherapy treatment, specific to their condition and treatment site.

John Velure, Empi's Senior Director of Marketing, said, "The Select(TM) product is the first in a new generation of pain-management devices that are so easy to use that we believe patients will be more compliant and achieve more predictable pain relief than any of its predecessors. We believe that healthcare providers will take great comfort in knowing that their patients are getting the most appropriate treatment for their specific conditions."

The Select(TM) device also includes a patented SMP waveform that delivers maximum pain relief through the use of both endorphin release and gate control pathways. "Empi's primary focus is to offer healthcare providers non-invasive, non-systemic solutions for managing pain, usually as a complement to standard pharmacotherapies," said Peter Baird, Group President - Therapeutic Devices of Encore Medical Corporation, parent company of Empi.

The Select(TM) device represents the cornerstone of Empi's brand revitalization efforts and is the first new electrotherapy device to be developed by Empi following its 2006 merger with Compex Technologies, Inc., which operated under the name Rehabilicare. The jointly developed product draws on the best of the engineering and legacy devices of both predecessor companies.

The Select(TM) device will be available from Family Practice, Pain Management, Orthopedic and other physicians in mid-February, 2007.

About Empi

Empi is a global medical technology leader in designing and manufacturing transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) devices, iontophoretic drug delivery systems, and splinting products used for pain management, rehabilitation and edema reduction in clinic, home healthcare, sports and occupational medicine settings. Empi is the largest operating division of Encore Medical Corporation, which is wholly owned by the Blackstone Group.

Further information is available at http://www.empi.com.

About Encore Medical Corporation

Encore Medical Corporation is a diversified orthopedic device company with leading positions in many of the markets in which it competes. Encore develops, manufactures and distributes a comprehensive range of high-quality orthopedic devices used for rehabilitation, pain management and physical therapy. It also develops, manufactures and distributes a comprehensive suite of surgical reconstructive implant products. Encore believes that it is one of a few orthopedic device companies that offer healthcare professionals and patients a diverse range of orthopedic rehabilitation and surgical reconstructive implant products addressing the complete spectrum of pre- operative, post-operative, clinical and home rehabilitation care.

Further information is available at http://www.encoremed.com.

About The Blackstone Group

The Blackstone Group, a global private investment and advisory firm, was founded in 1985. The firm has raised a total of approximately $59 billion for alternative asset investing since its formation, of which roughly $27 billion has been for private equity investing. The healthcare sector is one of Blackstone's core areas of focus, with current investments in pharmaceuticals, hospitals, nursing homes, healthcare services and health insurance. Blackstone's other core businesses include Private Real Estate Investing, Corporate Debt Investing, Hedge Funds, Mutual Fund Management, Private Placement, Marketable Alternative Asset Management, and Investment Banking Advisory Services.

Further information is available at http://www.blackstone.com.

Encore Medical Corporation
http://www.encoremed.com

Physical Therapy Can Help Relieve Boomers' Back Pain

2007-04-15T09:38:00.001-07:00

Because of increasingly demanding jobs, hectic daily schedules, participating in recreational activities, and caring for children, grandchildren, and elderly parents, back pain is becoming a common thread among baby boomers. However, this generation is less resigned to simply accept the changes brought about by aging, says the American Physical Therapy Association (APTA).

Baby boomers, those born between 1946 and 1964 and who now make up one fourth of the U.S. population, are leading more active lifestyles than previous generations. "Baby boomers are as active as they were when they were younger, but now they're living with chronic low back pain or osteoarthritis," says Jennifer Gamboa, PT, DPT, OCS, MTC, owner of Body Dynamics, a physical therapy private practice in Arlington, VA. "These conditions as well as others can benefit greatly from physical therapy intervention."

Back pain among baby boomers will be the subject of a toll-free national hotline on Thursday, February 15, from 9:00 am until 5:00 pm, Eastern Standard Time, sponsored by the American Physical Therapy Association's Orthopaedic and Sports Physical Therapy Sections. Physical therapists will be on hand to answer questions about injury prevention, exercise, and ways to prevent back pain. The hotline is offered as a public service to help people learn how to minimize back pain and is not a substitute for a visit to a physical therapist or other health care professional.

"Frequently, patients may unknowingly exacerbate their pain by exercising improperly or by having poor posture," Gamboa said. Physical therapists can help to identify and correct those behaviors. Physical therapists work on increasing muscle strength and cardiovascular endurance, restoring and improving range of motion in joints, and decreasing muscle and joint pain.

Physical therapy interventions may include therapeutic exercise, manual therapy, and functional training, as well as exercises for strength, flexibility, and range of motion, and devices designed to rest or support the joint, such as orthotics or splints. "The goal of a physical therapist is to get you back to doing what you enjoy on a daily basis with as little discomfort as possible."

For those patients who either are just starting an exercise regime, or for injured weekend warriors just getting back in the game, Gamboa recommends starting off slowly and not doing too much too fast. She notes that physical therapists devise step-wise plans in order for patients to gain strength and mobility.

Gamboa also suggests investing in an ergonomically correct chair for work, taking frequent breaks from computers, and participating in stress-relieving activities, such as yoga or meditation, to offset back pain.

Physical therapists (PTs) are health care professionals who diagnose and treat individuals of all ages, from newborns to the elderly, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. PTs examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability.

The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as physical therapy news and information at http://www.apta.org/consumer.

American Physical Therapy Association
http://www.apta.org/

Texas Back Institute Explores Dynamic Stabilization Procedures As Alternative To Traditional Spine Therapy

2007-04-15T09:35:00.001-07:00

The SpineMark Clinical Research Organization at Texas Back Institute in Plano, Texas, has taken the next step in offering patients multiple treatment options for spine care. Spinal fusions continue to be the standard of care for treating many disabling degenerative spinal conditions. But spinal fusions are not appropriate for everyone. In a move to provide patients with alternative therapies, SpineMark CRO at TBI is now enrolling patients in several clinical trials using motion preservation spinal devices aimed at maintaining natural movement.

Back pain has become a way of life for more than 50 million people in the United States. In 2005, an estimated 1 million surgeries were performed to correct spinal problems. That number exceeds the combined total of surgeries to replace hips or knees. The growing number of people with degenerative disc disease has created a major industry based on spinal fusion technology and products.

Today, the treatment of back pain and spinal problems is at a major crossroad. On one side is the public's desire to address chronic back pain through less invasive methods. The result has put a focus on new technologies that use smaller surgical incisions, or other methods aimed at preserving motion of the disc space, many without the need for fusion. On the other side, the FDA and spine surgeons in the U.S. are showing restraint in order to properly evaluate these new techniques before considering them a new standard of care.

The demand from patients and insurance companies for better treatment options has persuaded surgeons to look at the alternatives as well as the success rate for traditional fusion surgery. Data shows that the majority of lumbar fusion patients receive benefits from surgery. Extremely high success rates can now be attained from fusion procedures, but despite that, only about two-thirds of patients enjoy significant relief from back pain or regain desired function. Those published statistics are among the reasons why surgeons and their patients are looking to emerging technologies and new systems to deal with these spinal issues in a different way.

Public support for these new technologies can be seen in the dramatic growth of the industry. Sales of the emerging spinal motion preserving devices are increasing at an annual rate of 50 percent and should exceed $1.5 billion by 2009.

Patients with chronic back problems can access many of the leading traditional and motion preservation spinal devices being tested in the U.S. through SpineMark CRO at TBI in Plano, Texas. Patients are encouraged to speak with a spine care provider to discuss which option is best for their individual case.

Research studies for new spinal devices are directed at patients who are looking for the latest technology to bring their lives closer to normal. And with some of the best physicians and surgeons in the field of spinal care conducting these studies, participants will have that opportunity at the SpineMark CRO at TBI clinical research site.

"While fusions continue to be the gold standard, dynamic spine stabilization is at the forefront of advances in spine care," said Marcy Rogers, President and CEO of SpineMark Corporation. "We value the opportunity to participate in trials that could lead to additional treatment options for patients in search of a therapy that is right for them."

The implant market is the fastest growing market in healthcare. "Studies say that it will increase by 15-20 percent over the next 10 years," said Dr. Jack Zigler, president of SpineMark CRO at TBI. "In the interest of patients, it is important to get the new devices evaluated as efficiently as possible. The SpineMark CRO at TBI not only boasts an extraordinary physician and surgeon investigator group, but has married it to a clinical research organization infrastructure with solid and proven experience in regulatory compliance, stringent data collection, and patient safety monitoring. That combination is the ideal model for clinical research."

About SpineMark CRO at TBI

SpineMark CRO at TBI is the research arm for Texas Back Institute (TBI). TBI is one of the largest freestanding spine specialty clinics in the United States. The Institute, based in Plano, Texas, was established in 1978 and provides comprehensive medical care for individuals with back and neck pain. As an academic health care organization, TBI has trained hundreds of physicians, scientists and allied health professionals. SpineMark CRO at TBI employs state-of-the-art technology and research to treat patients and is involved in the most clinical trials of artificial discs. The professional staff there includes board-certified spine surgeons, general surgeons, internists, chiropractors, physiatrists, pain specialists, exercise physiologists and a team of physical and occupational therapists. SpineMark CRO at TBI's main office is located in Plano, Texas.

SpineMark Clinical Research Organization
SpineMark Clinical Research Organization

Chronic Pain Up Almost 40 Percent Among U.S. Workers In Past Decade

2007-04-15T08:40:00.001-07:00

Persistent, chronic pain has risen dramatically among full-time U.S. workers in the past 10 years, but workers today opt to go to their jobs rather than call in sick, leading to a growing trend of presenteeism -- a negative impact on work despite being physically present at the job.

These data, released today, are from a 2006 national survey conducted by Harris Interactive(R) on "Pain in the Workplace" (http://www.painandwork.com), sponsored by PriCara(TM), Unit of Ortho-McNeil, Inc., and conducted in partnership with the National Pain Foundation (NPF). The survey was an update to the 1996 Louis Harris & Associates poll on the subject, sponsored by Ortho-McNeil Pharmaceutical, Inc.

"Chronic pain appears to be increasing in prevalence among U.S. workers as Americans age and lead more sedentary lifestyles," said Rollin Gallagher, M.D., M.P.H., editor-in-chief of the NPF Web site (http://www.NationalPainFoundation.org), a founding and current member of the Board of the NPF and clinical professor and director, Center for Pain Medicine, Research and Policy of the University of Pennsylvania. "This survey indicates that employees with chronic pain must become their own advocates, understand the impact of their chronic pain and work with their healthcare provider to identify appropriate treatment options."

Chronic pain, defined in the survey as pain that lasts for at least six months, was more common in the workplace in 2006 than it was in 1996 (26 percent vs. 19 percent).

Today, almost nine in 10 employees with chronic pain (89 percent) typically go to work rather than stay home when experiencing chronic pain, the survey found. The same percentage of employees (89 percent) reported experiencing chronic pain at work "often" or "sometimes." Ninety-five percent of employees with persistent, chronic pain reported that their pain must be moderately severe or very severe to cause them to stay home from work.

"In my practice, I am seeing an increasing number of patients for chronic pain and hearing more patients talk about how their pain affects activities of daily living," said Charles Argoff, M.D., director and assistant professor of neurology, New York University School of Medicine, New York, New York. "They're looking for ways to manage their pain, and there are treatments that can help such as diet and exercise, physical therapy, acupuncture and a variety of over-the-counter and prescription medications. Extended-release chronic pain medications, such as prescription ULTRAM(R) ER (tramadol HCl) Extended-Release Tablets, taken once daily, have been shown to relieve moderate to moderately severe chronic pain in adults who need around-the-clock treatment for an extended period of time(1)."

Addressing Pain at Work

There have been positive changes in the workplace in the last decade. More than two-thirds, or 66 percent, of employers surveyed now offer worksite wellness programs to employees, compared to 40 percent in 1996. But while the number of wellness programs is relatively high, the number of programs addressing chronic pain is not. Only 22 percent of wellness programs include a component about preventing or living with chronic pain conditions.

"We have seen some improvement in the recognition of pain-related illness in the workplace, and that should be commended," said Dr. Gallagher. "But more U.S. businesses should invest in these wellness programs. Once employees are given the tools to better understand and manage their pain successfully, they can begin to improve many areas of their lives affected by their chronic pain."

About ULTRAM(R) ER

Important Safety Information

Tell your healthcare professional if you have had an allergic reaction to tramadol or other opioids in the past.

ULTRAM ER must be swallowed whole, and must not be chewed, crushed or split.

Seizures have been reported in people taking tramadol, the medicine in ULTRAM ER. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids or other drugs that can cause seizures. Risk of convulsions may also increase in people with epilepsy or a history of seizures.

Talk to your doctor if you are suicidal or have a history of drug addiction. Also talk to your doctor if you are pregnant.

ULTRAM ER should be used with caution in people taking medications such as tranquilizers, hypnotics or other opioids or alcohol. ULTRAM ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.

The most common side effects reported with ULTRAM ER were dizziness, nausea, constipation, sleepiness and feeling flushed.

For additional information and to see the full Prescribing Information, visit http://www.ULTRAM-ER.com.

About the Survey

The original "Pain in the Workplace 1996" survey was conducted by Louis Harris & Associates on behalf of Ortho-McNeil Pharmaceutical, Inc. The current "Pain in the Workplace 2006" survey was conducted by Harris Interactive(R) on behalf of PriCara(TM), Unit of Ortho-McNeil, Inc.

The 2006 survey was conducted via telephone within the United States by Harris Interactive between October 30 and December 3, 2006 among 1,103 employed U.S. adults age 18+ and 251 employment benefits managers at non-headquartered locations with 150 or more employees at the site. For the employees, figures for age, gender, race/ethnicity, education and region were weighted where necessary to bring them into line with their actual proportions in the population. The data for employment benefits managers were not weighted and represent only the opinions of those surveyed. With a pure probability sample of 1,103 and 251, one could say with a ninety-five percent probability that the overall results have a sampling error of +/-3 percentage points and +/-6 percentage points, respectfully. Sampling error for sub-samples would be higher and would vary. However, that does not take other sources of error into account.

The methodologies for the 1996 and 2006 surveys were identical and allow for accurate comparisons to be made between the data sets.

For more information on the survey, visit http://www.painandwork.com.

About the National Pain Foundation

The National Pain Foundation, a non-profit 501(c)(3) organization, was established in 1998 to advance functional recovery of persons in pain through information, education, awareness and support. The organization was created to serve the 75 million Americans living with chronic pain. Its goal is to empower patients by helping people in pain become actively involved in the design of their treatment plan, exploring both traditional and complementary approaches to pain management. For more information on the NPF, visit http://www.nationalpainfoundation.org.

The National Pain Foundation does not endorse or recommend any specific treatment, procedure, or product.

About PriCara(TM), Unit of Ortho-McNeil, Inc.

Ortho-McNeil, Inc., a Johnson & Johnson company, is headquartered in Raritan, NJ, and provides innovative, high quality prescription treatments for healthcare providers and their patients in primary care, hospitals and other care facilities. PriCara(TM), Unit of Ortho-McNeil, Inc., is the only major healthcare organization in the United States solely dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. Ortho-McNeil, Inc., and PriCara provide medicines, education and resources in the areas of pain, gastrointestinal and infectious diseases. For more information about the company, please visit http://www.PriCara.com.

References

(1) The National Pain Foundation does not endorse or recommend any specific treatment, procedure, or product.

PriCara (TM), Unit of Ortho-McNeil, Inc.
http://www.PriCara.com

Risk For Stroke, Death Not Higher For Sickle Cell Children With Early Complications

2007-04-15T08:36:00.001-07:00

Children with sickle cell disease who experienced major complications such as pain and lung disease early in life are at no greater risk for stroke or death during later childhood, new research from UT Southwestern Medical Center shows.

In addition, sickle cell children who have pain episodes ("crises") or dactylitis, a type of painful swelling of the hands and feet, as infants or toddlers are at no greater risk of having those symptoms recur in later childhood. The study's results, however, showed that children hospitalized for chest problems early on are more likely to see those problems recur up to adulthood.

The study following more than 200 children with sickle cell disease from birth through teenage years appears in the January issue of Blood, the scientific journal of the American Society of Hematology.

The findings are an important step in trying to identify predictors that reveal how the mysterious disease will progress as children age, said Dr. Charles Quinn, assistant professor of pediatrics at UT Southwestern and the study's lead author.

"Everybody who has sickle cell disease is affected differently by the disease. Some seem to have a lot of problems with pain and lung disease and some have very few problems and may have a normal life span," said Dr. Quinn. "We don't really understand why everyone with the same disease can be so different."

The myriad medical issues make it difficult when counseling parents of babies with sickle cell disease about what they can expect, he said. "We can't give them very much in the way of specifics, exactly what this child will likely go through or what to expect from the disease in the future," said Dr. Quinn, a pediatric hematology specialist at Children's Medical Center Dallas.

People with sickle cell disease have a genetic error in their hemoglobin. The disease turns the usually soft, round red blood cell that carries oxygen through the body into an inflexible, sickle-shaped cell that causes blockages in blood vessels and prevents body tissues from receiving oxygen. It is estimated that at least 70,000 Americans have the disease.

UT Southwestern researchers at Children's and at the National Institutes of Health-funded Southwestern Comprehensive Sickle Cell Center launched the study to try to determine whether problems from the disease in the first three years of life offered any indication of later problems.

They initially looked at whether some of the more common problems associated with sickle cell disease pain events, dactylitis and acute chest syndrome predicted early death or stroke. Researchers found that none of those factors result in higher risk.

But they did find that acute chest syndrome damaged lung tissue marked by fever, chest pain and difficulty breathing did correlate with recurrent episodes throughout the remainder of their childhood.

That may indicate a need for closer follow-up for those children and perhaps justify more aggressive treatment strategies.

Children hospitalized for acute chest syndrome and early painful events in the first three years also were at slightly higher risk for later painful episodes.

"Some doctors would think that if they have early pain, they are destined to have frequent pain later in life, but that's not necessarily the case," Dr. Quinn said.

The swelling condition dactylitis did not indicate any greater likelihood of pain episodes or lung disease up to adulthood, the UT Southwestern researchers found. "That finding in particular is at odds with other studies that showed that early dactylitis does predict later adverse outcomes," Dr. Quinn said.

Researchers reviewed cases of 264 children who are part of the Dallas Newborn Cohort, a unique patient pool started in 1983 when newborn screening for sickle cell disease was launched by the state. Researchers have been able to follow children with the disease to track how sickle cell patients fare. Earlier findings showed that children with sickle cell disease are living longer, dying less often from their disease and contracting fewer fatal infections than ever before.

Dr. Quinn said this latest step of identifying potential clinical signs is an important one for predicting the future for sickle-cell patients.

"This finding is something that could potentially be applied anywhere, whether you have a high-tech lab or you practice in a small clinic in a rural community," Dr. Quinn said. "We're always looking for something to help predict the future. Lots of investigators have looked at many laboratory markers with mixed results. What we did was to look at very simple, clinical manifestations of the disease that are easily seen by parents and by doctors and that didn't require any special laboratory or equipment to make this sort of prediction."

Also involved in the study were Dr. Zora Rogers, associate professor of pediatrics; Dr. George Buchanan, professor of pediatrics and director of the Southwestern Comprehensive Sickle Cell Center and the Barrett Family Center for Pediatric Oncology; and Elizabeth Shull, a registered nurse who collected the data.

About UT Southwestern Medical Center

UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members including four active Nobel Prize winners, more than any other medical school in the world are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.

UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
http://www.utsouthwestern.edu/

Emergency Departments Test Chest Pain Patients Differently, Based On Race, Gender And Insurance

2007-04-15T07:36:00.001-07:00

The study, conducted by Liliana E. Pezzin, Ph.D., associate professor of medicine at the Medical College, along with co-investigators Gary B. Green, M.D., MPH, and Penelope Keyl, Ph.D., at Johns Hopkins, appears in the February 2007 issue of Academic Emergency Medicine.

Chest pain is the most common initial symptom in patients diagnosed with coronary artery disease. Tests such as electrocardiography, chest radiography as well as oxygen saturation monitoring and cardiac monitoring are non-invasive and useful in diagnosing the disease. The study found that these tests are applied differently based on patients' race, gender and insurance.

Researchers drew on data compiled by the National Hospital Ambulatory Health Care Survey of Emergency Departments (NHAMCS-ED), from 1995 to 2000, for patients 30 years old or older presenting with chest pain. The retrospective study used a sample of 7,068 patients which corresponded to 32 million visits nationally throughout the six-year period.

They found that the rate of visits to emergency departments by patients presenting with chest pain increased in the six-year period, and that race, gender and insurance differences were factors in the type of care patients received at emergency departments.

Overall, African American males were 25 to 30 percent less likely to receive any of the tests than non-African American males.

Use of all forms of diagnostic testing and monitoring, with the exception of oxygen saturation monitoring, decreased among male African American patients over the six-year period. Electrocardiography decreased more than 16 percent among male African American patients, and they were 26 percent less likely to be placed on cardiac monitoring in 2000 than they were in 1995.

Gender was also an issue in determining what tests are administered for patients presenting with chest pain. African American women were approximately five percent less likely to have electrocardiography tests than non-African American men.

African American women were also 17 percent less likely to undergo cardiac monitoring, 14 percent less likely to have oxygen saturation monitoring, and six percent less likely to have chest radiography tests than non-African American men. Similarly, the rate of testing was lower for non-African American women than it was for non-African American men.

Insurance type was also proven to have a significant role in the administration of tests. Patients covered by forms of insurance other than commercial insurance were approximately 13 percent less likely to undergo electrocardiography. Additionally, patients covered by these forms of insurance were almost 21 percent less likely to be placed on cardiac monitoring, 23 percent less likely to have oxygen saturation measured, and more than 13 percent less likely to receive chest radiography than patients covered by commercial insurance.

The study also found that approximately 82 percent of commercially insured non-African American men received electrocardiography testing when presenting with chest pain in 2000. This is nearly a 27 percent higher proportion than uninsured African American men, and a 31 percent higher proportion than African American men covered by non-commercial forms of insurance.

###

The study was funded, in part, by a grant from the Agency for Healthcare Research and Quality.

Contact: Toranj Marphetia
Medical College of Wisconsin

Stem Cell Trial With Potential To Repair Hearts Damaged By Severe Coronary Artery Disease

2007-04-15T07:33:00.001-07:00

Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject's own stem cells can treat a form of severe coronary artery disease.

The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.

"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.

Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.

The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.

Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.

The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.

Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.

Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.

Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,

Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.

####

Coronary Artery Disease and Chronic Myocardial Ischemia

Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.

The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.

What are stem cells?

Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.

When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Source: National Institutes of Health

To participate in the study

The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..

About the NOGA Navigation System

The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.

The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.

The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.

About Rush

Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).

Contact: Mary Ann Schultz
Rush University Medical Center

Percutaneous Computerized Tomography Guided Renal Cryoablation Using Local Anesthesia: Pain Assessment

2007-04-15T06:37:00.001-07:00

UroToday.com- As the technique of laparoscopic and open cryoablation of renal tumors has been popularized, an increasing number of investigators have continued to raise the bar attempting similar ablations using a percutaneous technique.

In the September issue of the Journal of Urology, Permpongkosol, Kavoussi and colleagues from Johns Hopkins and North Shore-Long Island Jewish Health System report their experience with 25 patients with 30 renal tumors treated with cryoablation using only local anesthesia.

The mean patient age was 67 years (range 33 to 80) with a mean tumor size of 2.1 cm. Mean ice ball size was 4.1 cm. A mean of 44 cc of 1% lidocaine was injected in the skin, subcutaneous tissue, muscle and renal capsule along the tracts where the cryotherapy probes would be placed. Ablations were performed in the prone position using CT guidance with an average treatment time of 68 minutes. Pain scores were assessed during and after the procedure (scale 0 to 1).

Pain scores were zero before and after the procedure in all patients. Mean pain score after the first freeze was 1.8. Successful completion of ablation with local anesthesia only was completed in 85% of patients. Mean time to recovery was 112 minutes. Five complications occurred, including contrast allergy, transhepatic probe insertion with hematoma, perinephric hematoma with pleural effusion (2 units transfused), and 2 patients with transient nausea.

While these data suggest that percutaneous renal cryoablation using only local anesthesia is feasible, the question remains, what is the down-side of administering intravenous sedation in this setting, since it may be given with minimal morbidity with the added amnestic effects. Perhaps if a patient with a 2.1 cm mass has too many co morbidities to undergo conscious sedation, his renal mass should undergo active surveillance.

PermpongkosolВ S, SulmanВ A, SolomonВ SB, GongВ GX, KavoussiВ LR
J Urol 176(3): 915-918, 2006.

Reviewed by UroToday.com Contributing Editor Ricardo SГЎnchez-Ortiz, MD

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
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Copyright © 2006 - UroToday

Supplemental Therapy Can Ease Pain For People Suffering From Common Jaw Disorder

2007-04-15T06:34:00.001-07:00

A new supplemental therapy that teaches pain coping and biofeedback skills can reduce pain, the potential for chronic pain and health-care costs for millions of Americans suffering from a common jaw disorder, UT Southwestern Medical Center researchers have found.

The therapy certainly did the trick for Harriet Velevis, a Dallas pre-kindergarten teacher.

Her jaw used to throb with intense pain that made it hard to eat or do her job, and dental care provided little relief. But after participating in a UT Southwestern trial of the supplemental therapy, called early biopsychosocial intervention, she learned to self manage the pain. The intervention teaches a combination of coping techniques and tips on controlling stress-related bodily functions.

"Eventually I had no pain symptoms thanks to these techniques. I still use them today," Mrs. Velevis said. "For instance, I have a picture of a countryside scene in my classroom and I focus on it if I begin to grit my teeth or clench my jaw. Focusing on something that makes you happy helps your body relax."

UT Southwestern's trial evaluated early biopsychosocial intervention, which aims to help people at risk of developing chronic pain due to temporomandibular disorder, or TMD. The condition, which is associated with jaw or facial pain, affects more than 10 percent of Americans, making it the second-most common pain-causing muscular and skeletal condition, behind low-back pain.

Trial participants 20 men and 81 women who ranged in age from 18 to 70 were divided into two groups. One group got an intervention and standard dental care and the other received standard care alone.

The results, described in a study appearing online today in the Journal of the American Dental Association and in another study published in the journal's March 2006 issue, show that those who received the intervention had significantly lower levels of pain and fewer doctor visits.

Study participants in the intervention group also spent less money on treatment than those with no intervention, said Dr. Anna Stowell, assistant professor of psychiatry and anesthesiology and pain management at UT Southwestern and co-author of the studies. Standard care for TMD, such as medication, physical therapy and surgery, can be expensive.

"The early intervention can reduce TMD-related pain levels, stave off chronic pain and save people money on costly treatments," Dr. Stowell said.

In search of a low-cost supplement, researchers in this study combined two separately effective teaching techniques pain-coping and biofeedback skills into early biopsychosocial intervention.

The six-week intervention teaches patients about the mind-body relationship, the body's reaction to stress and relaxation training in everyday settings. Instruction also is given on biofeedback (the use of monitoring equipment attached to the body to record changes in muscle tension, respiration and temperature) to teach a person to control those functions generally considered involuntary.

About 50 of the study participants received the intervention and a year later reported reduced levels of pain. They also displayed improved coping abilities and better moods and emotions, Dr. Stowell said. The other half of the participants, who did not undergo intervention, made many more trips to a doctor to seek pain treatment. They also reported more general anxiety and other disorders.

"The intervention really helps people become more capable of managing pain," said Dr. Stowell, who works at the Eugene McDermott Center for Pain Management.

Other UT Southwestern researchers involved in the JADA study were Dr. Edward Ellis, professor of oral and maxillofacial surgery, and Dr. Robert Gatchel, clinical professor of anesthesiology and pain management and professor and chairman of psychology at UT Arlington. Another UT Arlington researcher and a Richardson dentist also were involved.

The National Institutes of Health-funded study has earned the Giddon Award for Distinguished Research in the Behavioral Sciences from the International Association of Dental Research.

About UT Southwestern Medical Center

UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members including four active Nobel Prize winners, more than any other medical school in the world are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.

UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
http://www.utsouthwestern.edu/

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Physical Therapy Can Help Relieve Boomers' Back Pain

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Texas Back Institute Explores Dynamic Stabilization Procedures As Alternative To Traditional Spine Therapy

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2007-03-05T08:30:00.001-08:00