A scary unknown for many children, the prospect of surgery can cause intense preoperative anxiety. While some amount of stress is normal, what many parents do not know is that extreme anxiety before surgery can contribute to the occurrence of emergence delirium, a distressing incidence of acute behavioral changes experienced when “waking up” from anesthesia.

Now in the July issue of Anesthesiology, physicians focused on reducing anxiety in children and their families report that oral treatment with melatonin before surgery can significantly reduce the occurrence of emergence delirium in children.

Affecting up to 20 percent of children who undergo surgery, emergence delirium in the postanesthesia care unit (PACU) consists of acute behavior changes including crying, thrashing and need for restraint. According to researchers, this can also lead to the development of behavioral changes outside the recovery suite with the onset of nightmares, bed wetting and separation anxiety.

“Studies conducted in adults have revealed that oral administration of melatonin before surgery beneficially reduced anxiety levels, but relevant similar treatment data for children undergoing anesthesia and surgery are limited,” said study lead author Zeev N. Kain, M.D., MBA, Chair of UC Irvine Anesthesiology and Associate Dean for Clinical Research at the UC Irvine School of Medicine.

Seeking confirmation of additional options for anxiety management, researchers first set out to determine if melatonin could decrease anxiety levels when compared to midazolam, a sedative widely used to ease preoperative anxiety. Melatonin is a hormone secreted by the pineal gland, regulates sleep, moods and reproductive cycles. Secretions of melatonin increase during exposure to light.

In a study group that consisted of 148 subjects between the ages of 2 and 8 undergoing outpatient surgery under general anesthesia, children were randomly assigned to receive midazolam or melatonin orally before surgery. Children were followed throughout their surgical experience as researchers measured anxiety and secondary study outcomes of anesthesia administration compliance and emergence behavior. Behaviors were measured using the Yale Preoperative Anxiety Scale (mYPass), the Induction Compliance Checklist and the Keegan scale.

“Results indicated that preoperative melatonin administration did not effectively reduce anxiety levels,” said Dr. Kain. “However, it was found that melatonin significantly reduced the incidence of emergence delirium in these children. As 3 million children undergo surgery in the U.S. each year, these findings reveal noteworthy health care and treatment implications.”

Melatonin showed a direct dose dependent effect on emergence delirium. Children in the melatonin premedication group received any of three doses of melatonin 0.05 mg/kg, .2 mg/kg and 0.4 mg/kg, while the incidence of delirium at each dose was 25 percent, 8.3 percent and 5.4 percent.

Midazolam remains the recommended premedication for anxiety reduction in children scheduled for surgery.

Source
Tom Vasich

Treatment with antitumor necrosis factor (TNF) agents is recognized as a risk factor for tuberculosis (TB) in patients with immunemediated inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, Crohns disease, psoriatic arthritis and psoriasis. Most TB cases develop as a result of reactivation of a latent TB infection, and health authorities worldwide recommend screening for latent TB and treating patients before initiating antiTNF treatment. A new study examined cases of TB associated with antiTNF therapy and found that the risk of TB is higher for patients receiving antiTNF monoclonal antibody therapy (infliximab or adalimumab) than for those receiving soluble TNF receptor therapy (etanercept). The study is published in the July issue of Arthritis & Rheumatism.

Led by Xavier Mariette of the Université ParisSud, researchers set up a national registry in France to collect all cases of TB occurring during a threeyear period in patients receiving antiTNF therapy for any reason. Researchers collected data on 69 cases of TB, assessing risk factors for TB before antiTNF therapy began and antiTNF treatment history.

The results showed that the risk of TB for patients receiving antiTNF therapy compared with the French population differed depending on the antiTNF agent used; those receiving monoclonal antiTNF therapy had a higher risk than those receiving sTNFR therapy. The risk of TB was higher during the first year of antiTNF treatment, which favored the reactivation of latent TB. None of the patients who received correct prophylactic treatment for TB which is in France in most of the cases the association of INH and rifampicione for 3 months. Two thirds of TB cases occured in patients with negative skin tests.

The authors note that other countries have set up registries to investigate the safety of antiTNF agents, but TB rates were so low that it was difficult to discern a difference in risk between the different types of antiTNF agents; the current study, however, clearly demonstrates this difference. This study examined TB cases in the entire French population and researchers were therefore able to collect many more cases. In addition, it is the only registry to collect safety data for patients receiving antiTNF therapy for any indication.

The mechanism by which TNF antagonists reactivate latent TB is not fully understood, but the authors suggest that differences in the action of the two types of antiTNF agents in specific T helper cells (which play an important role in maximizing the capabilities of the immune system) and T regulatory cells (which suppress activation of the immune system) may help explain the differences in the risk of TB that were observed. The authors conclude that the differences seen with the two types of antiTNF treatment may also explain the better efficacy of monoclonal antibody therapy in certain diseases, such as Crohns disease, sarcoidosis and uveitis.

Article “Risk of Tuberculosis Higher with Monoclonal Antibody Therapy Than with AntiSoluble Tumor Necrosis Factor Receptor Therapy,” F. Tubach, D. Salmon, P. Ravaud, Y. Allanore, P. Goupille, M. Bréban, B. PallotPrades, S. Pouplin, A. Sacchi, R.M. Chichemanian, S. Bretagne, D. Emilie, M. Lemann, O. Lorthololary, X. Mariette, Arthritis & Rheumatism, July 2009.

Source
Sean Wagner

Calixa Therapeutics Inc. today announced the initiation of a Phase 2 clinical trial of CXA101 in patients with complicated urinary tract infections. CXA101 is a new broadspectrum, parenteral cephalosporin antibiotic with excellent in vitro and in vivo activity against Pseudomonas aeruginosa, including drug resistant isolates. Calixa is investigating CXA101 as a potential treatment for serious bacterial infections in hospitalized patients.

The multicenter, randomized study is anticipated to enroll approximately 120 patients and will compare the efficacy and safety of CXA101 with the current standard of therapy. The primary efficacy endpoint for this study is microbiological outcome at the testofcure visit between six to nine days after the end of therapy.

“The preclinical and Phase 1 results to date are very promising and indicate that CXA101 is well tolerated and has broadspectrum antibacterial coverage, including potent activity against increasingly resistant gramnegative pathogens such as Pseudomonas aeruginosa,” said Dr. Ian Friedland, chief medical officer of Calixa. “We are going to present comprehensive preclinical and Phase 1 data at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy in September and other medical conferences. This Phase 2 study will generate important information on the safety and effectiveness of CXA101 in complicated urinary tract infections, which are usually caused by gramnegative pathogens”.

Eckard Weber, president and chief executive officer of Calixa and partner at the venture capital firm Domain Associates, LLC said, “With the continually increasing incidence of serious and lifethreatening infections caused by resistant gramnegative bacteria and the paucity of new drugs in the pipeline to counter such resistance, we are working diligently to expedite the development of CXA101. We are fully committed to providing patients and physicians with a much needed option for the treatment of lifethreatening infections caused by gramnegative bacteria.”

About Calixa Therapeutics

Calixa Therapeutics Inc. is a biopharmaceutical company committed to the development and commercialization of novel medicines for the treatment of infectious diseases. The companys initial focus is on developing novel antibiotics for use in the hospital setting. Calixa Therapeutics, which is privately held, is headquartered in San Diego and has operations in the San Francisco Bay Area.

As Vietnams industrial capabilities have developed rapidly in recent decades, government officials have recognized the importance of helping to secure the nations supply of medicines. In an important milestone addressing this need, the Vietnamese Pharmacopoeia Commission (VPC) has signed a memorandum of understanding (MOU) with the U.S. Pharmacopeial (USP) Convention. USP is a scientific nonprofit organization that sets standards for the identity and quality of prescription and overthecounter drugs that are enforced by the U.S. Food and Drug Administration in the United States. USP also sets standards for the identity and quality of food ingredients and dietary supplements; these and USPs drug standards are used in more than 130 countries.

At a signing ceremony at the Institute of Drug Quality Control in Ho Chi Minh City, Roger L. Williams, M.D., USPs chief executive officer, said, “I am delighted to work with colleagues here in Vietnam and elsewhere in Asia to help ensure the quality of medicines around the world.” Nguyen Van Tuu, Ph.D., chairman of the VPC, concurred “Vietnamese regulators and manufacturers look forward to working closely with USP to reach our shared goal of good quality medications.” An industry leader who witnessed the ceremony commented that the Vietnamese pharmaceutical industry welcomes the collaboration between VPC and USP and is looking forward to the benefits of this collaboration.

The MOU is focused on building a collaborative working relationship through such activities as developing new and updated written standards; mutual testing of potential reference standards; scientist exchange programs, joint participation in planning and policy meetings, and identifying specific projects to improve drug quality that will benefit from the expertise of both parties. USP is based in the United States and has offices and laboratories in Shanghai, China; Hyderabad, India; São Paulo, Brazil; and an office in Basel, Switzerland. To further its mission to help ensure good quality medicines and food ingredients throughout the world, USP has formed similar partnerships with drug control authorities in these and many other countries.

Source
Francine Pierson

Diabetes UK is asking you to donate your unwanted or broken jewellery and accessories to our jewellery appeal.

We will then convert your kind donations into crucial funds to support diabetes research projects.

If you have an odd cufflink or earring, a watch that doesnt tick, a damaged necklace or a ring that doesnt fit, please send it to the address below.

Where to send your jewellery

Old Jewellery Appeal
Diabetes UK
FREEPOST LON12854
London
NW1 2YF

Make all the difference

Dominic Littlewood, copresenter of the One Show and of Strictly Come Dancing fame has Type 1 diabetes. He said “The number of people with diabetes in the UK has increased dramatically in recent years. As somebody with Type 1 diabetes I know first hand just how difficult it can be to manage the condition and about the serious associated complications like stroke and heart disease.

UroToday.com Prostate and breast cancer appear to be homologous cancer in males and females respectively. Both cancers share hormone etiologies and are treated with hormonal manipulation. The incidence of these two hormonedependent cancers has steadily risen throughout the twentieth century. Both cancers have racebased links there is a higher incidence of prostate cancer in AfricanAmerican men than Caucasian men followed by Asian men and under the age of forty, breast cancer is more lethal in AfricanAmerican women than Caucasian women and Asian women[12] . Beyond genetic and cultural explanations for these differences, an alternative environmental hormone disruptor may be at play as follows.

The cessation of the Womans Health Initiative (WHI) in July 2002 precipitated a reduction in hormone replacement therapy (HRT) and was followed by a decline in breast cancer incidence in 2003 and 2004 [3] . However, with increasing use of male testosterone replacement therapy there has not been an associated increase in prostate cancer incidence [4] . This suggests the existence of another source of longterm inadvertent and unintentional hormonal exposure common among men and women to support a common etiology between prostate and breast cancer.

This featured abstract reveals an overlooked source of hormones reservoirs of cutaneous generated hormones and pheromones (androgens), primarily from the “axillary organ” [5] . Apocrine sweat glands are concentrated in the axillae. Estrogen, testosterone, and androgenbased pheromones are contained within these apocrine sweat glands, and nearby cutaneousaromatase convert testosterone and androstenedione to estradiol and estrone respectively [69] . Apocrine sweat secretion is initiated through emotion or stress as well as physical activity. These odorfree secretions become odorous through cutaneous bacterial transformation prompting a currently estimated global annual expenditure of $10 billion on antiperspirants to obstruct the normal function of the axillary organ [10] . Antiperspirants are considered drugs by the United States Food and Drug Administration (FDA) because they affect the function of the body by reducing the amount of sweat that reaches the skin. By not being allowed to reach the skin, the hormonally laden sweat remains on and within the skin, making the antiperspirants potential endocrine disruptors as defined by the United States Environmental Protection Agency (EPA) [1112] .

Underarm generated hormones and pheromones, which may number greater than onehundred, are within the optimal molecular weight range of commercially available transdermallydelivered drugs (TDD). The optimum TDD environment is the skin with skinappendages, (hair follicle; sebaceous, eccrine, and apocrine glands), and is optimal within the axilla [13] . Antiperspirants possible triggering of “Pharmaceutical” TDD of unintended and inadvertent hormones and pheromones could begin in utero, and continue through the preteen, puberty, and adult years. This chronic, unnatural exposure could occur to developing prostate and breast buds, as well as to mature tissue. Prostate and breast tissues each contain both androgen and estrogen receptors. Plotting breast cancer incidence and mortality against kg/1000 person usage of antiperspirants from 74 countries, reveals positive trendlines.

The median surface of a single axilla is 64.5 cm2, 135.5 cm2 representing 0.36%, 0.64% of total body surface area in women and men respectively. Underarm product application for females is higher by a factor of 1.6 compared to the median value for males [14] . In Loretz et. als study, solid antiperspirant underarm application occurring one to two times delivered an estimated mean 0.79g, with 98.7% of subjects using the product on any given day [15] . Possible explanations for the gender, racial and ethnic prostate and breast cancer epidemiological differences noted above are(1) apocrine sweat glands are more developed and occur more often in women and are larger in AfricanAmericans, followed by Caucasian and Asian individuals [1617] ; and

(2) apocrine sweat gland size is less in Asians, larger in whites, and largest in AfricanAmericans.This may explain prostate cancer incidence at all ages per 100,000 is highest AfricanAmericans 217.5, is next in Caucasians 147.6, and lowest in Asians 83.7. However, this same observation is not seen in breast cancer incidence at all ages per 100,000 where Caucasian is highest with 124.3, next is AfricanAmerican 116.8, Asian 87.7 is the lowest. However, a trend however is seen when incidence is ageadjusted, ages 2049. The prostate and breast cancer incidences per 100,000 for ages 2049 for prostate/breast are AfricanAmerican 18.4/72.2, Caucasian 8.2/70, and Asian 1.85/60.9 [1}. Within the context of this concept, sex and hygiene may influence the outcomes with womens apocrine glands being larger and more developed regardless of race, and women applying underarm products more frequently than men.

Through time the underarms have become more occluded as humankind has progressed from hunting and gathering, to farming, to factory work, to office work, with less physical activity via the automobile, and to the desk at a keyboard. And ironically, thermal sweating from physical activity has been usurped by emotionalstress based sweat, potentially affected by daily interference of an underarm endocrine organ by antiperspirants, furthering underarm occlusion and possibly placing men and women in harms way.

Thus far, circumstantial historical and multidiscipline observations, although persuasive, are insufficient to conclude an etiological link between antiperspirant and prostate and breast cancer. Further confirmatory investigations are required in an effort to eventually offer prevention and reduced incidence and mortality from the worlds two most common hormonedependent cancers.

References

1 National Cancer Institute. Surveillance epidemiology and end results [accessed 052009].
2 Donavan M, Tiwary CM, Axelrod D, et al. Personal care products that contain estrogens or xenoestrogens may increase breast cancer risk. Med Hypotheses 2007; 68 756766.
3 Ravdin PM, Cronin KA, Howlander N, et al. The decrease in breast cancer incidence in 2003 in the United States. N Engl J Med 2007; 356(16) 16701674.4 Raynaud JP. Prostate cancer risk in testosteronetreated men. Steroid Biochem Mol Biol 2006; 102 261266.
5 Grammer K, Fink B, Neave N. Human pheromones and sexual attraction. Eur L Obstet Gynecol Reprod Biol 2005; 118 135142.
6 Chen W, Thiboutot D, Zouboulis CC. Cutaneous androgen metabolism Basic research and clinical perspectives. J Invest Dermatol 2002; 119 9921007.7 Rittmaster RS. Androgen conjugates Physiology and clinical significance. Endocr Rev 1993; 14(1) 121132.
8 Zouboulis CC, Chen WC, Thorton MJ, et al. Sexual hormones in human skin. Horm Metab Res 2007;39 8595.
9 Thorton MJ. The biological actions of estrogens on skin. Exp Dermatol 2002; 11 487502.
10 Market sizes. Historical forcastvolume consumption. Antiperspirant kg per 000 people. Chicago, IL Euromonitor International Inc.; 2008.
11 Food and Drug Administration. Department of Health and Human Services. Antiperspirant drug products for overthecounter human use; final monograph. Federal Register 2003; 683427334293.
12 National Center for Environmental Research. United States Environmental Protection Agency. What are endocrine disruptors?.
13 Scheindlin S. Transdermal drug delivery past, present, future. Mol Interv 2004; 4 308312.
14 CowanEllsberry CMcNamee, Leazer T. Axilla surface area for males and females Measured distribution. Regulatory Toxicol and Pharmacol 2008; 52 4652.
15 Loretz L, Api AM, Barraj L, et al. Exposure data for personal care products Hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. Food and Chem Toxicol 2006; 44 20082018.
16 McGrath KG. Apocrine sweat gland obstruction by antiperspirants allowing transdermal absorption of cutaneous generated hormones and pheromones as a link to the observed incidence rates of breast and prostate cancer in the 20th century. Med Hypotheses 2009; 72 665674.
17 Hurley HJ, Shelly WB. Introduction,The nature of apocrine sweat, Disorders of the apocrine gland. In Hurley HJ, Shelly WB eds. The human apocrine sweat gland in health and disease. Springfield, IL Thomas; 1960 pp 39, 7699.

Written by Kris G. McGrath, MD as part of Beyond the Abstract on UroToday.com.

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 tourotoday.com

FDA on Wednesday approved Watson Pharmaceuticals generic version of the emergency contraceptive Plan B, the Wall Street Journal reports. The generic drug will be available without a prescription to women ages 18 and older on Aug. 24, when Duramed Pharmaceuticals market exclusivity for Plan B expires (Kalish, Wall Street Journal, 6/25). The generic version will be available to women ages 17 and younger with a prescription, according to an FDA press release (FDA Web site, 6/24). Watson will market the generic version under the name Next Choice (AP/Washington Post, 6/24).

A onetime use pack of the brandname product, Plan B, currently costs $49.99 through the online retailer DrugStore.com. According to Bloomberg, generic drugs usually cost 30% to 80% less than brandname versions (Larkin, Bloomberg, 6/24).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Community Care Market News has conducted an annual survey of local authority fee rates for nursing and residential care.

Baseline fee rates for the 200,000 council supported elderly people in independent sector care homes across the UK have received an average uplift of 2.6% for financial year 2009/10, according to Laing & Buissons annual survey published in the June edition of Community Care Market News. This is a slight fall compared to the 3% increase seen in last years round of uplifts.

Alzheimers Society comment

Everyday over 250, 000 people with dementia in care homes need care and support. Good care homes show us that good care can make a huge difference to peoples quality of life but sadly there is a huge variation in the quality of care being delivered. Often the difference between good care and poor care is the amount of money invested in resources, training, support and staff.

In these times of unprecedented fiscal stringency and low rises in baseline fee, councils and care homes must show extra vigilance when commissioning for quality care. The proposed green paper on Adult Funding of Social Care must also deliver a transparent, fair and sustainable system of who pays for care.

Neil Hunt
Chief Executive
Alzheimers Society

Notes

Baseline fee rates are defined as the gross weekly fee that local authorities are prepared to pay independent sector nursing and residential homes for the care of individuals for whom they accept financial responsibility.

The Department of Health is expected to publish a green paper setting out proposals for the longterm reform of adult social care funding in June 2009.

One in three people over 65 will die with dementia

Alzheimers Society research shows that 700,000 people in the UK have a form of dementia, more than half have Alzheimers disease. In less than 20 years nearly a million people will be living with dementia. This will soar to 1.7 million people by 2051.

Alzheimers Society champions the rights of people living with dementia and the millions of people who care for them.

Alzheimers Society works in England, Wales and Northern Ireland.

Alzheimers Society needs to raise money to help people live well with dementia today and for research to find a cure for tomorrow. You can donate now by calling 0845 306 0898 or visiting alzheimers.org.uk

Alzheimers Society provides a National Dementia Helpline, the number is 0845 300 0336 or visit alzheimers.org.uk

This is one of the findings of Sophia Shaw and colleagues from the University of Leicester who will present their research at the British Psychological Society Division of Forensic Psychology Annual Conference today, Tuesday 23rd June, at the University of Central Lancashire, Preston.

First, 101 men aged between 18 and 70 completed questionnaires regarding their sexual history, personality and aggression. They were then asked to imagine themselves in different scenarios with one woman but varying her dress, how much alcohol she had drank, how assertive she was and how many previous sexual partners she had.

Men who considered themselves sexually experienced were willing to coerce the woman to a later stage in the scenario than those with less sexual experience. These men also reported that they found resistance from a woman sexually arousing.

Alcohol, however, had the opposite effect than predicted, with participants more likely to coerce women who were sober rather than drunk.

Sophia explained “Previous research has suggested that women are more likely to be raped by someone they know, yet they fear rape by strangers more. This study was concerned with examining the factors that lead men to have a greater likelihood to commit rape in scenarios involving a woman who was an acquaintance.”

“We can see from the results that sexually experienced men are more likely to coerce women in sexual situations; even more so if they believe the women to be sexually experienced.”