The US back pain market for drug treatment will be valued at almost $23 billion in 2018, according to US Back Pain, a report released today by WWMR, Inc. Growth in this market will be driven largely by the opioid agonist products that are currently in development. Many of these are long-acting, abuse-resistant formulations that are highly anticipated in the clinical community. If pipeline products deliver on efficacy and safety, uptake is likely to be considerable and at premium prices.

WWMR estimates that the US back pain market in 2008 was valued at $17 billion and dominated by opioid drugs, a trend expected to continue throughout the next decade.

Only a few of the many drugs in development for pain conditions are seeking regulatory approval for back pain; nonetheless, many agents will compete for patients and share in this market. Abuse-resistant opioids like tapentadol CR and the antidepressant duloxetine (Cymbalta) have the greatest potential for success among the new agents in late-stage development.

In 2008 an estimated 91 million people in the US suffered from either acute, chronic neuropathic or chronic non-neuropathic back pain, including pain in the neck/upper back or lower back. In the report WWMR provides prevalent US patient pool estimates (2008) and projections (2013 and 2018) for each of these five types of back pain.

WWMR also provides market value estimates for 2008 and projections to 2018 by drug class, which takes into consideration the five major causes of back pain: mechanical disorders; rheumatic disorders; spinal metabolic disorders; spinals tumors; and failed back surgery (post-laminectomy) syndrome. Interviews with primary care physicians and pain clinicians, as well as data from WWMR’s US Pain Clinic Monitor provide additional perspective on the back pain market. WWMR’s US Pain Clinic Monitor is an audit of more than 100 pain clinics that includes prescribing data on back pain and more than 30 other pain indications.

In the development pipeline more than 170 agents worldwide could have the potential to treat back pain, with 10 agents in active clinical trials specifically for the treatment of back pain. Among the 170, 60 agents are in development for indications closely related to back pain, such as musculoskeletal pain, inflammatory pain, acute pain and neuropathic pain. All of these agents are reviewed in this report. Currently, worldwide, there are 39 agents in late-stage (Phase III+) development with a potential to treat back pain. The 5 late-stage compounds that are being studied specifically for the treatment of back pain are Eli Lilly’s SNRI Cymbalta, Abbott’s Vicodin CR (an extended release formulation of the popular hydrocodone/APAP combination), Cephalon’s Fentora, an effervescent oral formulation of fentanyl, Pfizer’s Celebrex, which is seeking regulatory approval in Japan for the treatment of back pain, and Ortho-McNeil/ Grunenthal’s tapentadol controlled release, an opioid receptor agonist/ norepinephrine reuptake inhibitor.

ADDITIONAL SERVICES AND REPORTS BY WWMR, INC. INCLUDE:

  • US Pain Clinic Monitor (available now)
  • 2008 US Neuropathic Pain (available now)
  • 2008 US Cancer Pain (available now)

Source: WWMR, Inc.


In light of the recent recall of eggs by den Dulk farms due to Salmonella, California-based food safety expert Jeff Nelken is strongly advising Americans, especially pregnant women, children and those 55 or older, to take precautions when eating eggs at home or in restaurants.

More than 93 percent of Americans consume eggs, potentially one of the most dangerous foods in terms of food-borne illness. The Center for Disease Control and Prevention (CDC) estimates that Salmonella illness is responsible for 1.4 million illnesses, 15,000 hospitalizations and 400 deaths in the U.S. annually. Salmonella side effects can range from gastrointestinal distress to arthritis and even death. At-risk groups, including pregnant women, children under 10, those 55 or older or those with a compromised immune system due to disease or illness are at risk for major complications, including bone marrow disease, heart valve damage and if pregnant, miscarriage.

“Eggs have always been a high risk food due to the number of eggs that carry Salmonella and the potential cross contamination within the kitchen,” said Nelken, who has advised food manufacturers, restaurant chains and others on food safety issues for years. “Many think that cooking, cleaning or refrigerating can eliminate Salmonella. Not true! You must cook it to 160 degrees and if you don’t, just one egg with Salmonella, mixed in with others for a larger dish or tracked through a kitchen, has the potential to sicken hundreds.”

Nelken said that three out of 10 Americans still eat their eggs in styles that are undercooked such as over easy and sunnyside up and seven of 10 Americans eat scrambled eggs, which can also pose a risk if they are served softly scrambled. The best way to deal with Salmonella in foods is to remove the risk before it enters the kitchen, Nelken said.

He recommends using only pasteurized shell or liquid eggs when cooking to eliminate potential cross contamination. Some tips from Nelken to ensure food safety when prepping and cooking:

1. Cook your foods to the proper temperatures; eggs need to reach 160 degrees throughout. Cook eggs to a point where yolks and whites are solidified. Use a thermometer to be sure.
2. Purchase pasteurized eggs — make sure the label says pasteurized — and enjoy a full range of foods such as eggs over easy, cookie dough or Caesar salad, without the risk associated with non-pasteurized eggs.
3. Wash hands frequently when handling raw egg products and before and after handling eggs.
4. Refrigerate eggs. Make sure not to expose eggs to the “danger zone” temperatures of between 41-135 degrees Fahrenheit.
5. Don’t be afraid to ask how food is prepared when dining out. Make sure kitchens practice food safety preparation. Kitchens should not save egg wash, use batter containing eggs from one meal to the next or pool eggs. Don’t eat eggs that are prepared in lightly cooked styles unless pasteurized shell eggs are used.

If consumers have eggs involved in the recall, they should contact the store where they were purchased. If consumers are not sure about the eggs they have, they should call their local health department.

Source: National Pasteurized Eggs


Mayo Clinic research shows a correlation between inadequate vitamin D levels and the amount of narcotic medication taken by patients who have chronic pain. This correlation is an important finding as researchers discover new ways to treat chronic pain. According to the Centers for Disease Control and Prevention, chronic pain is the leading cause of disability in the United States. These patients often end up taking narcotic-type pain medication such as morphine, fentanyl or oxycodone.

This study found that patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication — nearly twice as much — as those who had adequate levels. Similarly, these patients self-reported worse physical functioning and worse overall health perception. In addition, a correlation was noted between increasing body mass index (a measure of obesity) and decreasing levels of vitamin D. Study results were published in a recent edition of Pain Medicine.

“This is an important finding as we continue to investigate the causes of chronic pain,” says Michael Turner, M.D., a physical medicine and rehabilitation physician at Mayo Clinic and lead author of the study. “Vitamin D is known to promote both bone and muscle strength. Conversely, deficiency is an under-recognized source of diffuse pain and impaired neuromuscular functioning. By recognizing it, physicians can significantly improve their patients’ pain, function and quality of life.”

Researchers retrospectively studied 267 chronic pain patients admitted to the Mayo Comprehensive Pain Rehabilitation Center in Rochester from February to December 2006. Vitamin D levels at the time of admission were compared to other parameters such as the amount and duration of narcotic pain medication usage; self-reported levels of pain, emotional distress, physical functioning and health perception; and demographic information such as gender, age, diagnosis and body mass index.

Further research should document the effects of correcting deficient levels among these patients, researchers recommend.

This study has important implications for both chronic pain patients and physicians. “Though preliminary, these results suggest that patients who suffer from chronic, diffuse pain and are on narcotics should consider getting their vitamin D levels checked. Inadequate levels may play a role in creating or sustaining their pain,” says Dr. Turner.

“Physicians who care for patients with chronic, diffuse pain that seems musculoskeletal — and involves many areas of tenderness to palpation — should strongly consider checking a vitamin D level,” he says. “For example, many patients who have been labeled with fibromyalgia are, in fact, suffering from symptomatic vitamin D inadequacy. Vigilance is especially required when risk factors are present such as obesity, darker pigmented skin or limited exposure to sunlight.”

Assessment and treatment are relatively simple and inexpensive. Levels can be assessed by a simple blood test (25-hydroxyvitamin D [25(OH)D]). Under the guidance of a physician, an appropriate repletion regimen can then be devised. Because it is a natural substance and not a drug, vitamin D is readily available and inexpensive.

In addition to the benefits of strong muscles and bones, emerging research demonstrates that vitamin D plays important roles in the immune system, helps fight inflammation and helps fights certain types of cancer.

Other study authors from Mayo Clinic include W. Michael Hooten, M.D., Department of Anesthesiology; John Schmidt, Ph.D., Department of Anesthesiology Research; and Jennifer Kerkvliet, Cynthia O. Townsend, Ph.D., and Barbara Bruce, Ph.D., all from the Pain Rehabilitation Center.

Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. Doctors from every medical specialty work together to care for patients, joined by common systems and a philosophy of “the needs of the patient come first.” More than 3,300 physicians, scientists and researchers and 46,000 allied health staff work at Mayo Clinic, which has sites in Rochester, Minn., Jacksonville, Fla., and Scottsdale/Phoenix, Ariz. Collectively, the three locations treat more than half a million people each year. To obtain the latest news from Mayo Clinic, go to www.mayoclinic.org/news. MayoClinic.com (www.mayoclinic.com) is available as a resource for your health stories. For more on Mayo Clinic research, go to www.mayo.edu.


Herbalife Protein Shake Proven Effective in Clinical Study

  • Author: Health Informer
  • Filed under: Health News
  • Date: Mar 22,2009

Over the past several decades, the United States has seen dramatic increases in the incidence of obesity. But the epidemic is not confined to this country; similar increases are being seen worldwide as other countries adopt Western high-calorie foods and a sedentary lifestyle.

Recent data from the National Statistics Office in Korea, for example, indicate that nearly a third of Koreans – about 10 million people – are overweight, with numbers increasing by about 400,000 annually.

Researchers at the Seoul National University Hospital in Korea recently reported that the use of meal replacements twice daily was an effective strategy for reducing body weight and body fat, and for improving indicators of obesity-related conditions.

The study, published in the February issue of the International Journal of Clinical Practice, followed 75 obese men and women with the metabolic syndrome – a cluster of factors including high blood pressure, a large waist measurement, elevated blood sugar and triglycerides, and low blood levels of “good” HDL cholesterol – for a period of 12 weeks.

All subjects replaced two meals a day with liquid meal replacements (Herbalife Formula 1, Korean formula) but were randomly assigned to consume a diet of either a standard amount of protein – about 15 percent of total calories – or double the amount of protein from a higher protein plan.

At the end of 12 weeks, both groups lost weight and both groups lost weight in the belly area. But, in the subjects who followed the diet most strictly, the people in the high protein group lost more body fat (and less lean body mass) than the people consuming the standard amount of protein.

“These findings indicate that meal replacements are a very valuable strategy for losing weight and body fat,” said Belong Cho, M.D., Ph.D., of the Department of Family Medicine at Seoul National University Hospital and lead researcher on the study. “With the increasing incidence of overweight and obesity in Korea, there is a critical need to find ways to help individuals lose weight and decrease their risk of developing obesity-related disorders such as the metabolic syndrome,” he added.

The incidence of the metabolic syndrome in Korea has increased from 18.6 percent to 23.6 percent between 1998 and 2001, paralleling similar increases – from 34.5 percent to 39 percent – over the same time period in the U.S. Dr. Cho added, “We have demonstrated the effectiveness of meal replacements for weight loss, and this approach could have far-reaching benefits in addressing obesity which has become a worldwide problem.”

Cho is a member of Herbalife’s Nutrition Advisory Board (NAB). The NAB is made up of leading experts around the world in the fields of nutrition and health who educate and train Herbalife independent distributors on the principles of nutrition, physical activity and healthy lifestyle.

The NAB is chaired by David Heber, M.D., Ph.D., director of the Center for Human Nutrition at the University of California, Los Angeles (UCLA).

Source: Herbalife Ltd.


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