Diabetelogia, the journal of the European Association for the Study of Diabetes (EASD), published a series of research papers today examining a possible link between insulin glargine (brand name, Lantus) and cancer. Findings from these research papers are conflicting and inconclusive, and the American Diabetes Association cautions against over-reaction until more information is available.

Four different population based studies were reported and published in Diabetelogia and the data within these studies and between these studies are conflicting and confusing. Until more information is available, the American Diabetes Association advises patients using insulin not to stop taking it.

For patients using glargine and considering switching to another form of insulin, the data in these studies make it unclear as to whether any one type of insulin increases the risk of cancer more than other types of insulin.

Patients concerned about these studies or their insulin regimen should talk to their doctor and should not stop taking their insulin on the basis of the findings reported here.

Insulin is a hormone normally produced by the pancreas that helps the body use glucose for energy. All people with type 1 diabetes need to take insulin to survive; many patients with type 2 diabetes also need to take insulin to control their blood glucose.

Glargine insulin, which as been widely used since 2000, is an artificial form of insulin that is typically administered once a day.

Source
American Diabetes Association

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While many people believe that Seasonal Affective Disorder (SAD) amounts to feeling gloomy in the winter, a University of Rochester research review emphasizes that SAD is actually a subtype of major depression and should be treated as such.

Lead author Stephen Lurie, M.D., Ph.D., an assistant professor of Family Medicine at the University of Rochester Medical Center, also noted that SAD is sometimes missed in the typical doctor’s office setting.

“Like major depression, Seasonal Affective Disorder probably is under-diagnosed in primary care offices,” Lurie said. “But with personalized and detailed attention to symptoms, most patients can be helped a great deal.”

New, preliminary studies link SAD to alcoholism or Attention Deficit Hyperactivity Disorder (ADHD). However, not all people with SAD will have ADHD, according to the review article for the American Academy of Family Physicians.

“The important message here is that if you are a patient who has been diagnosed with a mental illness of any kind, don’t just assume that any new mental or emotional problem is due to that illness,” Lurie said. “Specifically, if you have ADHD and you feel worse in the winter, don’t just assume it’s your ADHD getting worse. It could actually be SAD – and you should see your doctor because ADHD and SAD are treated entirely differently.”

Although SAD has only been studied in adults, parents of children with ADHD should be sensitive to seasonal patterns of behavior and report any changes to a doctor, Lurie said.

Emerging evidence also shows that a pattern of seasonal alcohol use or abuse is associated with SAD. Patients might be self-medicating to cope with an underlying depression, researchers said.

Treatment for SAD includes light therapy, medications such as antidepressants, and cognitive behavior therapy. Each option seems to be effective, Lurie said, but none has been proven superior.

For some patients, SAD is precipitated by darker days causing a shift in 24-hour hormonal rhythms. The loss of natural light outdoors can be replaced with treatment by indoor light-therapy units designed for SAD. Light therapy is best delivered in the morning, when it can regulate the daily pattern of melatonin secretion, the review said.

Treatment with cognitive therapy has been shown to improve a person’s dysfunctional thoughts and attitudes and other symptoms in patients with major depression, but no large studies have established whether this type of treatment is effective for SAD.

Doctors often prescribe antidepressants such as Zoloft for SAD. But most of the clinical studies have compared the drug therapy to a placebo pill rather than to light therapy, making it difficult to determine if one treatment is better, the review said.

Contact: Leslie Orr

University of Rochester Medical Center

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Sales of Merck’s HPV vaccine, Gardasil, declined by a third this year, and three years after the FDA approved the drug an estimated three out of four women remain unvaccinated despite millions spent on advertising and lobbying for government mandates. A recent marketing study offers a reason.

Michelle Steward, assistant professor of marketing at Wake Forest University, and several colleagues conducted an experiment with women, ages 18 to 30, and found that they were more likely to consider being vaccinated for HPV after participating in a survey than as a result of commercial advertising or a government mandate.

“The educational cues in the survey are the least coercive and appear to prompt more thinking about the risks of not being vaccinated than laws, which may produce a negative backlash or advertisements, of which consumers might be skeptical,” said Steward.

“The results would suggest that Merck’s money may be best spent engaging people through a survey on relevant health topics to get the consumer to think about their own risks. There’s nothing to suggest that there would be any difference in males’ reactions. If Merck gains FDA approval to market Gardasil for boys, the advantages of surveys versus mandates or advertising would remain the same.

“Determining how best to move consumers from hearing about a drug or vaccination to actually using the product should rival R&D in importance to a firm,” Steward said.

The study, “The Influence of Different Types of Cues-to-Action on Vaccination Behavior: An Exploratory Study,” will be published in the spring edition of the Journal of Marketing Theory and Practice.

Steward is available to discuss the study and its implications for the marketing of health-related products.

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Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, is launching two new hands-on training systems- the Lap Nepherctomy simulation module and the VirtaMed TURPSim. Both solutions will be revealed for the first time at the AUA annual meeting in San Francisco next week.

The Lap Nephrectomy simulation system is a unique replication of one of the most advanced laparoscopic procedures. While studies show that the laparoscopic nephrectomy procedure offers improved quality of life at lower costs, it is at the same time considered to be a challenging surgery with a steep learning curve. The solution provided by Simbionix will enable urologists to practice the procedure in a virtual clinical environment without risks to patients or recurring training costs. It is expected that the potential for unlimited access to training may reduce intra-operational complications associated with this procedure.

The new VirtaMed TURPSim simulation system is the latest development from VirtaMed who joined forces with Simbionix in 2009 to provide GYN and Urologist surgeons with the most advanced training systems for endoscopic surgery. Trans-Urethral Resection of the Prostate (TURP) is the current gold standard in the treatment of Benign Prostate Hyperplasia (BPH). With a wide range of prostate anatomies, pathologies and operative complications, this technique requires skills training and experience to achieve optimal results. The new VirtaMed TURPSim provides comprehensive training on the skills necessary to perform this procedure and will enable practice of complete TURP procedures using an authentic resectoscope.

Gary Zamler, Simbionix CEO, commented “Simbionix is a pioneer in the field of medical education, and for the past ten years has continuously introduced ground breaking technology that has changed and shaped the face of medical education. Our commitment to the medical community is to provide all medical fields with new and advanced training tools, as demonstrated by these latest developments intended for urologists. Our strong partnership with VirtaMed is based on this same philosophy intended to advance clinical performance.”

“The combination of TURPSim and HystSim provides a realistic platform for full procedural training in both urology and gynaecology. We are excited to continue our collaboration with Simbionix to ensure that every training center has the option to add the TURPSim to its training portfolio,” says VirtaMed CEO Stefan Tuchschmid. “VirtaMed will continue to focus on developing new simulators with the highest possible realism, and Simbionix is a partner who supports us in every possible way.”

About Simbionix USA Corporation

Simbionix is the world’s leading provider of simulation and training products for medical professionals and the healthcare industry. Founded in 1997, the company is committed to delivering high quality products, advancing clinical performance and optimizing procedural outcomes. Simbionix cooperates with physicians on a regular basis to produce the most reliable and effective training and supporting systems

About VirtaMed

VirtaMed is a Swiss based company with an interdisciplinary background in medicine and engineering. The HystSim(TM) and TURPSim(TM) systems are the first VirtaMed product and provide instructional teaching and training of hysteroscopy and the transurethral resection of the prostate. VirtaMed’s mission is to develop state-of-the-art training tools for endoscopic surgery of highest possible realism, all with the ultimate goal to improve the quality of patient care.

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Scientists at Case Western Reserve University’s School of Medicine have published in the Journal of Inflammation a remarkable discovery with a natural product derived from the Amazon rainforest. The discovery’s unique actions suggest a broad set of applications in various joint, skin and gastrointestinal diseases, including osteoarthritis and irritable bowel syndrome.

The publication revealed that Progrado®, an extract from a rainforest tree called Croton palanostigma, was a remarkably potent antioxidant and prevented the destruction of human cartilage by molecular s scissors called matrix metalloproteinases (MMPs). According to the researchers, these enzymes cut collagen, which forms the backbone of the cartilage, into tiny pieces during states of inflammation and alter the fabric that holds tissues together.

“This is an exciting finding,” said Tariq Haqqi, professor of medicine at Case Western Reserve University/University Hospitals of Cleveland and the lead investigator and senior author of the study. “This is the first time a natural product has been shown to directly block these molecular scissors while showing potential to stimulate repair. This is a testament to the wound healing properties of this traditional medicine and the distinctive therapeutic opportunities that nature offers.”

Haqqi’s research partner, Rainforest Nutritionals Inc., of Raleigh, N.C., develops innovative therapeutics from natural products and worked with the university on the discovery of Progrado®.

Rainforest Nutritionals, along with Haqqi, also developed Reparagen®, a natural product for joint health, with a grant from the National Institutes of Health (NIH), which also awarded the company with an Innovation Research Award to foster Reparagen’s® development and commercialization.

Paul Bobrowski, co-author of the study and vice president of Rainforest Nutritionals, said Progrado’s® molecular targets are highly prized and could lead to a range of therapeutic innovations for conditions ranging from arthritis, irritable bowel disease and wrinkles based on their involvement in tissue injury/repair and aging.

“The publication of these results reflects the commitment that Rainforest Nutritionals has to scientific excellence and innovation using products derived from nature to promote health and an improved quality of life,” Bobrowski said. “These results also build on our success with the highly-effective natural product for joint health, Reparagen®, with our NIH-funded preclinical research performed in collaboration with Dr. Haqqi.”

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Prescribing ambulatory oxygen in patients with chronic obstructive pulmonary disease (COPD) improves exercise performance, but not the quality of their daily life unless they have resting hypoxemia, according to researchers in Toronto.

“Ambulatory oxygen therapy is routinely prescribed for those who do not meet criteria for mortality reduction,” wrote Roger S. Goldstein, M.B., Ch.B., Professor of Medicine and Physical Therapy at West Park Healthcare Centre in Toronto, lead author of the study. “[This study] suggests serious problems with the indiscriminate use of oxygen to relieve day-to-day dyspnea in patients with COPD without resting hypoxemia.”

The study, which indicates that generalized treatment of COPD patients with ambulatory oxygen may be an unnecessary and inconvenient, and possibly even detrimental expense, appeared in the second issue for August of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

For many patients, a diagnosis of COPD comes with a prescription for ambulatory oxygen, even when they do not meet the standard criteria for long-term oxygen treatment (LTOT). In 2002, Medicare paid $2.2 billion for home oxygen therapy.

The researchers conducted a series of double-blind N-of-1 trials wherein 27 COPD patients without resting hypoxemia underwent three pairs of two-week trials, using either oxygen or compressed air (as a placebo). At the end of each trial period, patients were assessed with the Chronic Respiratory Questionnaire (CRQ) and St. George’s Respiratory Questionnaire (SGRQ), and given a timed walk test to assess their exercise performance. Neither the patients nor the assessors were aware of whether they had received oxygen or placebo during the trials.

As a group, the patients on oxygen showed improvement in the number of steps taken in the walk test, but no improvement in their dyspnea scores or on their questionnaires. When assessed as individuals who served as their own controls, four patients showed improvement in the dyspnea scores with oxygen, and only one was identified as a “clear responder,” whose overall scores and walk tests improved markedly on oxygen, and who requested early termination of the placebo phase of the trial during all three periods.

“Although ambulatory oxygen acutely improved constant power endurance and a standardized home walking test, very few patients experienced benefit from oxygen at home,” wrote the researchers.

These results are consistent with those in previous studies, which have likewise found that improvements in exercise capacity and endurance do not translate into perceived benefits in dyspnea and quality of life. However, one investigation in patients who had completed a pulmonary rehabilitation program, did find differences in the CRQ, suggesting a benefit from oxygen to more active patients.

These findings raise important questions about identifying patients who stand to benefit from oxygen. “One approach to the issue is to restrict oxygen use to patients who show benefit from an N-of-1 trial,” the researchers suggest, noting that while the costs of such trials are not negligible, they are “considerably less than the cost of providing long-term ambulatory oxygen for patients who do not benefit from it.”

The study also “challenges us to learn what supplemental oxygen therapy can accomplish when coupled with an exercise program designed to potentiate oxygen’s effects,” wrote M. Bradley Drummond, M.D., and Robert A. Wise, M.D., of Johns Hopkins University School of Medicine, in an accompanying editorial. “Continued efforts with innovative approaches…will allow the treatment of COPD to move away from the limited data of the past into a future where COPD no longer damages and shortens the lives of so many.”

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Particular components of inflammasomes – protein complexes needed for generating immune responses to pathogens and cellular damage – lessen the severity of colitis and colitis-associated colon cancer in mice, according to a study published online this week in the Journal of Experimental Medicine.

Compared to healthy humans, patients with ulcerative colitis, a form of inflammatory bowel disease, have a higher risk of developing colorectal cancer. As the inflammasome is typically associated with activation of the immune system, Jenny Ting and co-workers suspected that mice lacking inflammasome components would be more resistant to colitis and associated colorectal cancer.

Unexpectedly, mice lacking some but not all inflammasome components developed more severe colitis and larger tumor burdens in the colon.

Additional work is needed to determine how specific inflammasome components protect against colitis in mice, and whether inflammasomes play similar roles in humans.

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Although Pfizer does not normally comment in advance on the expected timing of regulatory submissions, it issued the following statement today to address recent analyst comments regarding the regulatory filing of SUTENT in the U.S.

Pfizer plans to file its investigational new drug SUTENT (sunitinib malate) for metastatic renal cell and gastrointestinal stromal cancer indications during August.

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ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced that the company received expanded indications from the U.S. Food and Drug Administration (FDA) for its AQUACEL(R) and AQUACEL(R) Ag Dressings with Hydrofiber(R) Technology for the management of surgical wounds that heal by primary intent, building upon the products’ extensive indications for chronic and acute wounds.

AQUACEL(R) and AQUACEL(R) Ag Dressings are soft, absorbent barrier wound dressings which feature the unique gelling benefits of ConvaTec Hydrofiber(R) Technology. AQUACEL(R) Ag Dressing also provides the broad-spectrum antimicrobial properties of ionic silver, which kills a broad range of pathogens in the dressing, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).(1)

“Approximately 27 million surgical procedures are performed annually in the United States.(2) ConvaTec is extremely pleased that, with this expanded indication, health care professionals will now be able to safely and effectively use both AQUACEL(R) and AQUACEL(R) Ag Dressings across a broad spectrum of wounds related to surgical incisions,” said Marcus Schabacker, Chief Scientific Officer.

In addition to the new indication for the management of surgical wounds that heal by primary intent (including dermatologic, orthopedic and vascular incisions), the initial indication for use in surgical wounds left to heal by secondary intent was clarified to specifically encompass dehisced surgical incisions. AQUACEL(R) Ag Dressing also received an expanded indication for the management of infected wounds.

“The expanded indication for use in orthopedic wounds is particularly significant,” added Schabacker. Blistering, often associated with orthopedic dressings, can lead to infection, delay healing and increase hospital length of stay.(3) “AQUACEL(R) and AQUACEL(R) Ag Dressings provide an effective alternative for the management of orthopedic surgical wounds.”

These latest indications for AQUACEL(R) and AQUACEL(R) Ag Dressings follow the expanded indication each received from the FDA in 2007 for the management of painful wounds. The unique gelling action of Hydrofiber(R) Technology has been shown to reduce wound pain while the dressing is in situ and help reduce the pain and trauma upon dressing removal.(4) Hydrofiber(R) Technology is also featured in the company’s recently launched Versiva(R) XC(TM) Gelling Foam Dressings.

These dressings gel on contact with wound fluid, which is locked inside the dressing to protect the periwound skin, while maintaining a moist environment to support healing and protect newly formed tissue from damage on removal.

According to a study published last year in the Journal of the American Medical Association, the estimated number of patients in the United States developing invasive MRSA infections in 2005 was 94,360.(5) Approximately 85 percent of those infections were associated with health care delivery,(5) and approximately 14 percent of those infections occurred in persons without obvious exposures to health care settings.(5)

According to the Centers for Disease Control and Prevention, surgical site infections are the third most frequently reported hospital-acquired infections, accounting for 14 to 16 percent of all nosocomial infections among hospitalized patients.(2)

AQUACEL(R) and AQUACEL(R) Ag Dressings have been studied in numerous randomized clinical trials across a variety of chronic and acute wounds, including pressure ulcers, leg ulcers, diabetic foot ulcers, partial thickness (second degree) burns and surgical incisions.

About ConvaTec

ConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key business divisions — Ostomy Care, Wound Therapeutics, Continence and Critical Care and Infusion Devices — ConvaTec products support health care professionals from the hospital to the community health setting. From its headquarters in Skillman, New Jersey, the company oversees more than 8,000 employees in over 90 countries serving consumers and their health care professionals on six continents. For more information, please visit convatec.

References

1. Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber dressing. Wound Repair Regen. 2004;12(3): 288-294.

2. Surgical Site Infections. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. cdc/ncidod/dhqp/dpac_ssi_data.html. Accessed November 17, 2008.

3. Gupta, SK, Lee S, Moseley LG. Postoperative wound blistering: is there a link with dressing usage? J Wound Care. 2002;11(7):271-273.

4. Vanscheidt W, Lazareth I, Routkovsky-Norval C. Safety evaluation of a new ionic silver dressing in the management of chronic ulcers. WOUNDS. 2003;15(11):371-378.

5. Klevens RM, Morrison M, Nadle J. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007;298(15):1763-1771.

AQUACEL, DuoDERM, Hydrofiber and Versiva are registered trademarks of ConvaTec Inc.

XC is a trademark of ConvaTec Inc.

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“The blood froze in my veins” or “My blood curdled” – these common figures of speech can be taken literally, according to the latest studies. Indeed, more literally than some of us would like. For it turns out that intense fear and panic attacks can really make our blood clot and increase the risk of thrombosis or heart attack.

Earlier studies showed that stress and anxiety can influence coagulation. However, they were based almost entirely on questionnaire surveys of healthy subjects. In contrast, the Bonn-based research team around Franziska Geiser (from the Clinic and Policlinic for Psychosomatic Medicine and Psychotherapy) and Ursula Harbrecht (from the Institute of Experimental Haematology and Transfusion Medicine) have been the first to conduct a very careful examination of coagulation in patients with anxiety disorders.

Everyone experiences anxiety from time to time – fear of failing the math’s test, dread of going down into the dark cellar or, in a more general sense, trepidation about what the future holds. But some people are gripped by powerful fears when confronted by quite normal everyday situations. For example, sufferers of agoraphobia frequently have panic attacks when caught up in a crowd. The symptoms can be dramatic: palpitations, sweating, shaking, blind panic or fainting – even leading to death. Another anxiety disorder frequently encountered can be described as social phobia. Those affected fear above all situations in which they become the centre of attention in a group. They begin to stutter or turn red. In order not to avoid embarrassment, social phobia sufferers may become recluses, shying away from human contact and staying at home.

The medical researchers in Bonn compared patients who suffer from a severe form of panic disorder or a social phobia with a healthy control group. In order to rule out as far as possible the influence of factors like age and sex, each of the 31 patients with anxiety disorders was matched with a corresponding healthy patient of the same age and sex. The subjects first had to give blood samples and were asked to perform a number of tests on the computer. A second blood sample was then taken. The blood analysis, which measured various coagulation factors, produced a clear result: The group of anxiety patients showed a much more highly activated coagulation system than the healthy control group.

In the coagulation system two mechanisms operate that are indispensable to life and normally work in opposite directions, each counterbalancing the other. On the one hand, coagulation involves a thickening of the blood so that a plug can form and prevent excessive bleeding from damaged vessels. On the other hand, there is “fibrinolysis”, a process that keeps the blood fluid and breaks down clots. In the case of the anxiety-disorder patients, however, the researchers observed through close analysis of the blood an activation of coagulation accompanied by an inhibition of fibrinolysis. Yet, apart from the prick for blood sampling, no real injury had occurred. For these types of patients, the coagulation system goes out of balance as the coagulation tendency rises – possibly with dangerous consequences. In extreme cases the imbalance can lead to blockage of a coronary artery.

The increased coagulation tendency could, says Franziska Geiser, be the “missing link” that explains why anxiety patients have a statistically higher risk of dying from heart disease by a factor of 3 or 4. “Of course, this doesn’t mean that every patient with a marked anxiety disorder must now worry about having a heart attack. The coagulation values we measured were always within the physiological scale, which means there is no acute danger,” adds the project leader. A real health threat only arises when other risk factors, like smoking and obesity, also come into the equation.

Franziska Geiser also has some good news for people with anxiety disorders. A follow-up study has produced the first evidence that coagulation activation subsides in patients who have completed successful therapy for their condition. In this respect, Dr. Geiser calls for earlier diagnosis of anxiety disorders, pointing out that too much time is wasted before effective psychotherapy is prescribed. “After all, we have programmes to help the population give up smoking or take more exercise. But if we want to reduce the number of heart disorders, it would make sense to improve the way anxiety disorders are diagnosed and treated.”

This release is available in German.

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