Lance Armstrong Unveils Global Cancer Awareness Campaign and Details of His Return to Cycling

Today, Lance Armstrong, cancer survivor, cycling champion and founder and chairman of the Lance Armstrong Foundation (LAF), announced the creation of the LIVESTRONG(TM) Global Cancer Awareness Campaign focused on supporting the 25 million people living with cancer worldwide, dispelling the misconceptions surrounding the disease and urging world leaders to make cancer a greater priority.

“I’m returning to cycling in order to raise awareness of the global cancer burden,” said Mr. Armstrong. “While my intention is to train and compete as fiercely as I always have, this time I will gauge victory by how much progress we make against cancer, a disease that will claim 8 million lives this year alone. Our campaign will appeal to every person affected by cancer as well as their nations’ leaders and we intend to visit, race and train in those countries that join our cause. We will reach out to those who suffer in silence and connect them with a community of cancer survivors to give them strength and hope. And we will appeal to world leaders, asking for their help in fighting a disease from which millions die needlessly. United, we can win the fight against cancer.”

Cancer is a leading cause of death that is projected to claim 12 million lives by 2030. Deaths due to cancer outnumber those caused by AIDS, tuberculosis and malaria combined. Following 18 months of worldwide research, the LAF found widespread misconceptions, stigma and lack of awareness associated with cancer. For many countries, cancer is considered a death sentence, causing people to avoid seeking prevention, detection and treatment. Because many still believe cancer to be contagious, those affected by the disease are frequently isolated and stigmatized by their communities. Often, the causes of the disease and the growing success in treating cancer are unknown.

Mr. Armstrong unveiled the LIVESTRONG(TM) Global Cancer Awareness Campaign before world leaders, policy makers and non-profit organizations gathered at the opening session of the Clinton Global Initiative in New York. Speaking to attendees, Mr. Armstrong appealed for their support and invited them to attend the LIVESTRONG(TM) Global Cancer Summit, scheduled for July 28, 2009, in Paris, following the Tour de France.

“I am so pleased that Lance Armstrong and his foundation made a commitment to increase their efforts to raise awareness and inspire action to fight cancer on a global scale,” President Clinton said. “This campaign is a great example of what can be done to address pressing challenges in new and measurable ways — which is what the Clinton Global Initiative is all about.”

New York City Mayor Michael Bloomberg was among the first to lend his support to raising cancer awareness around the world.

“Tens of millions of eyes will be on the Tour, and this is our chance to captivate a captive audience,” said Mayor Bloomberg. “Awareness is a key to cancer prevention and this is a once-in-a-lifetime opportunity to make people aware of what they can do and how they can get involved.”

Mr. Armstrong also revealed details of his return to cycling. He will be reuniting with Johan Bruyneel, his long time team director and the architect of his seven Tour de France wins, on Team Astana. Mr. Armstrong described a rekindled desire throughout the past year to reengage in professional cycling. His commitment to the sport and to its growth is exemplified by his long-term partnership with Mr. Bruyneel as a Pro Tour rider and owner, as a mentor and owner of the Trek Under 23 Developmental Team, and as a local owner of a bike shop in Austin, Texas.

Mr. Armstrong also announced his commitment to changing the culture of drug testing in professional sports through his team’s retention of Dr. Don Catlin, a leading expert in identifying and detecting the use of performance enhancing drugs in professional sports. Dr. Catlin will design the most comprehensive program ever implemented for a professional athlete. The goal of the program will be to change current thinking about testing and make it possible for athletes to prove they are racing clean rather than trying to prove they did not cheat. All of Lance’s blood work and testing will be posted online at www.livestrong.com.

“Lance has been very specific about his desire for the complete transparency and availability of his results,” said Dr. Catlin. “The program we have developed for him will be thorough, rigorous and leave no room for speculation.”

Mr. Armstrong also announced highlights of his racing schedule which will include the Tour Down Under in Australia beginning January 18, 2009 (his first race since the 2005 Tour de France), and the Tour de France which begins July 4, 2009, in Monaco.

Biography: Don Catlin, M.D., CEO of Anti-Doping Research & Professor Emeritus at the UCLA School of Medicine

For 26 years, Dr. Don Catlin has been at the forefront of the global battle against the use of performance-enhancing drugs in sports, and he is often referred to as one of the fathers of drug testing in sport. In 1982, Dr. Catlin founded the UCLA Olympic Analytical Laboratory, the first anti-doping lab in the United States, and served as its director for 25 years. Under his stewardship, the lab grew to become the world’s largest.

At the UCLA Olympic Lab, Dr. Catlin oversaw the drug testing at the 1984 Summer Olympic Games in Los Angeles, the 2002 Winter Games in Salt Lake City, the 1994 Soccer World Cup and the testing for anabolic agents at the 1996 Summer Games in Atlanta. Among other breakthroughs, he and his lab team developed the testing methodology that differentiates natural from artificial testosterone; inaugurated the test for darbepoetin, a long-acting form of the blood booster medicine EPO; were first to report the use of a designer steroid (norbolethone) in sport; and marshaled the analytic work behind the BALCO scandal, which involved identifying the designer steroid THG.

In 2005, as part of an effort to keep up with the continual introduction of new and ever-evolving performance-enhancing drugs in competition, Dr. Catlin and colleagues founded Anti-Doping Research (ADR), a non-profit organization dedicated to research and testing development. One of ADR’s current priorities is developing a reliable urine test to detect the use of human growth hormone (hGH) — a long-sought-after goal that Dr. Catlin believes is within reach.

Dr. Catlin also serves as Professor Emeritus of Molecular and Medical Pharmacology at the UCLA School of Medicine and is the author of over 100 articles in scientific publications. He is a member of the World Anti-Doping Agency Health, Medical and Research Committee and a member of the International Olympic Committee Medical Commission, the two organizations charged with oversight of the drug testing at the 2008 Summer Olympic Games in Beijing.

About the Lance Armstrong Foundation

The Lance Armstrong Foundation (LAF) unites people through programs and experiences to empower cancer survivors to live life on their own terms and to raise awareness and funds for the fight against cancer. The LAF focuses on cancer prevention, access to screening and care, research and quality of life for cancer survivors. Founded in 1997 by cancer survivor and champion cyclist Lance Armstrong, the LAF has raised more than $260 million for the fight against cancer and distributed more than 60 million LIVESTRONG(TM) wristbands to help make cancer a global priority. This year, the LAF became a supporter of the World Cancer Declaration endorsed by the UICC World Cancer Congress 2008. The LAF encourages all individuals to show their support by signing the declaration at www.livestrong.org.

 Contact: Katherine McLane Lance Armstrong Foundation (512) 279-8384 Email Contact  Mark Higgins Capital Sports & Entertainment (512) 370-1919 Email Contact

SOURCE: Lance Armstrong Foundation

Dallas Cardiologists Explore ‘Next Frontier’ in Vascular-Disease Treatments

DALLAS, Sept. 24 /PRNewswire-USNewswire/ — Presbyterian Hospital of Dallas is one of only a handful of medical centers in the United States — and the only Texas facility — to broadcast live interventional cases to the prestigious Vascular InterVentional Advances conference, held this week in Las Vegas, Nev.

The VIVA conference will educate over 1,000 physicians and medical personnel on the latest advances in the treatment of peripheral vascular disease (PVD), a looming health crisis as the U.S. population ages and more Americans battle obesity.

Drs. Tony Das and James Park, interventional cardiologists at Presbyterian Hospital of Dallas, will perform cases from Presbyterian’s cardiac catheterization lab. The procedures will be transmitted in high-definition to the conference in Las Vegas, where cardiac experts from around the world will be assembled.

“With the prevalence of diabetes and obesity among an already aging population, the challenges facing those involved in the diagnosis and treatment of peripheral vascular disease are overwhelming,” Dr. Das said. “It’s a problem that will increasingly challenge medical experts around the country in coming years.”

Other sites for live cases include The Cleveland Clinic and the University of California Davis Medical Center.

PVD is a common condition affecting more than 10 million adults in the United States. The condition is a disease of blood vessels outside the heart and brain characterized by a narrowing of vessels that carry blood to the legs, arms, stomach and kidney.

The live cases from Presbyterian will demonstrate complex vascular procedures to open and stent arteries supplying the kidneys, focusing part of their session on the increase in renal artery disease in the United States. Other cases will focus on techniques to open complex blockages of the femoral and tibial arteries, which supply blood to the lower limbs. If untreated, the condition can lead to tissue and limb loss.

A new technique to treat these blockages involves using a tiny crown coated with diamond chips that rapidly spins at high speeds and sands away plaque inside arteries — while preserving the healthy tissue of the arterial wall. Orbital rotational force causes the tip of the device to expand inside the artery as it slowly sands away plaque and opens the artery to restore proper blood flow.

“These treatments are among our best tools to treat peripheral vascular disease and restore blood flow to the legs and feet,” said Dr. Kenneth Saland, an interventional cardiologist at Presbyterian who will perform cases during the conference. “Advanced treatments like these are keys to effective limb salvage.”

The Research and Education Institute for Texas Health Resources (TREI) provided technical support and assistance in the preparation and production for this event to happen through the Presbyterian Institute for Minimally Invasive Technology (PIMIT).

Texas Health Resources

CONTACT: Stephen O’Brien, Public Relations manager, Texas HealthResources, +1-214-345-4960, +1-214-759-2584 (Pager),[email protected]

Web Site: http://www.texashealth.org/

Research Shows How AHCC(R) May Help Fight Flu and Other Infectious Agents

PURCHASE, N.Y., Sept. 24 /PRNewswire/ — A new paper published in Nutrition Reviews (Vol. 66(9):526-531) by Dr. Barry W. Ritz, PhD, Department of Bioscience and Biotechnology at Drexel University, has shown how AHCC impacts the immune response against a number of infectious agents.

The scientific review analyzed outcomes from in vivo studies evaluating the effect of AHCC supplementation on immune response following challenge with a variety of infectious agents such as the influenza (flu) virus, avian influenza (bird flu), Methicillin-Resistant Staphylococcus aureus (MRSA), Klebsiella pnuemoniae and Candida albicans. It was reported that supplementation with AHCC modulated immunity and delivered positive results in response to acute virus and bacterial infections.

“Studies with AHCC in multiple models of infectious disease, including the viruses that cause seasonal flu and bird flu, suggest that AHCC can stimulate the immune system and help the body respond to a broad spectrum of infectious threats,” says Barry Ritz, Ph.D., Professor of Bioscience and Biotechnology at Drexel University.

Research completed with AHCC has shown that it activates important immune white blood cells including macrophages, NK cells and LAK cells. AHCC also induces the production of cytokines that serve as chemical messengers between cells. AHCC has been the subject of over 80 research studies worldwide including studies completed at Harvard University’s Faulkner Hospital, Yale University and Columbia University Medical Center.

In addition to these studies, further investigation is being done examining the role of AHCC in humans for its ability to impact the T cells related to cellular immunity and determining if AHCC supplementation can serve as a beneficial vaccine adjuvant for the flu shot.

What is AHCC (Active Hexose Correlated Compound)?

AHCC is derived from the hybridization of several subspecies of medicinal mushroom, cultivated in Japan and then produced from a unique manufacturing process. AHCC is the leading immune-enhancing supplement in Japan and is utilized by over 700 hospitals and healthcare facilities worldwide as a standard preventative supplement for incoming patients to help reduce the risk of hospital infections as well as supporting the body’s fight against the formation of abnormal cells.*

AHCC is manufactured by Amino Up Chemical Company in Sapporo, Japan and is distributed in the United States by Maypro Industries. Maypro sells AHCC to a number of leading supplement companies including Quality of Life Laboratories, a subsidiary of Maypro.

The AHCC Research Association was founded in 1986 to promote further study. Each year since 1994, over 300 medical doctors and researchers have gathered in Sapporo, Japan for the AHCC Research Association Symposium to share and discuss the latest developments.

To learn more about AHCC, visit the AHCC Research Association Web site at http://www.ahccresearch.com/

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or mitigate disease.

AHCC Research Association

CONTACT: Steve Hanson of GRIP IDEAS, +1-602-430-7246,[email protected], for AHCC Research Association

Web Site: http://www.ahccresearch.com/

Sanofi-Aventis Wins FDA Approval for Nasacort AQ Nasal Spray

Sanofi-Aventis has announced that the FDA has approved Nasacort AQ nasal spray for children aged two to five years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

The FDA based its approval on the results of a multicenter, randomized, double-blind, placebo-controlled study demonstrating that Nasacort AQ can be used safely and effectively to treat nasal symptoms of year-round allergies in children between two and five years.

This is said to be the first and largest placebo-controlled trial designed to specifically investigate both the efficacy and safety of an intranasal corticosteroid versus placebo in two to five years of age group.

Steven Weinstein, director of allergy and asthma specialist medical group in Huntington Beach, California, said: “We welcome this new treatment option for our very young patients. Nasacort AQ nasal spray has been proven effective for the age groups two to five years to relieve nasal allergy symptoms.”

Who Will Be The ‘Hot Bod’ at the Olympia?

NORTH BERGEN, N.J., Sept. 24 /PRNewswire/ — If you’ve ever been to Joe Weider’s Olympia Weekend, you know it can get very, very hot in Vegas. With the help of The Vitamin Shoppe and BodyTech.com it’s about to get even hotter! Vitamin Shoppe is offering an opportunity for two participants to realize their dream of being a star and be featured in Muscle & Body magazine.

Joe Weider’s Olympia Weekend 2008 expo will begin on Friday, September 26 and end Saturday, September 27 at 5:00 pm. During the open showcase times, all expo goers are invited to drop by the Vitamin Shoppe and Bodytech.com booth to have their photograph taken to enter the contest. Twenty finalists will be featured in October online at http://www.vsconnect.com/, Vitamin Shoppe’s online community of customers, bodybuilding pros and other health and wellness experts. The winners will be notified by Muscle & Body magazine in early November 2008.

Some well known “hot bods” will be visiting the booth including Rich Gaspari from Gaspari Nutrition, Lee Banks — NPC National level bodybuilder ranked 2nd in the country, and JBL — John Bradshaw Layfield the longest reigning WWE Champion as well as a World Tag Team champion, US Champion, Hardcore Champion, European Champion and successful entrepreneur, financial advisor, and radio host of his own show.

Free give aways at the booth include T-Shirts, sports nutrition samples, Muscle & Body magazine and informative information.

“We’re excited to be a part of Joe Weider’s Olympia Weekend for the third time,” said Claudia Cribeiro, Event Manager for The Vitamin Shoppe. “At The Vitamin Shoppe we strive to help all our customers achieve their wellness goals.”

About Vitamin Shoppe Industries, Inc.

Vitamin Shoppe is a leading specialty retailer and direct marketer of nutritional products based in North Bergen, New Jersey. The company sells vitamins, minerals, nutritional supplements, herbs, sports nutrition formulas, homeopathic remedies, and other health and beauty aids to customers located primarily in the United States. The company carries national brand products as well as exclusive products under the Vitamin Shoppe, BodyTech, MD Select, and VS Basics proprietary brands. The Vitamin Shoppe conducts business through more than 370 company-owned retail stores, national mail order catalogs, and two websites, http://www.vitaminshoppe.com/ and http://www.bodytech.com/.

Vitamin Shoppe Industries, Inc.

CONTACT: Susan McLaughlin of Vitamin Shoppe, 1-866-921-4443,[email protected]

Web Site: http://www.bodytech.com/http://www.vitaminshoppe.com/http://www.vsconnect.com/

MD2 International Brings Highly Attentive Medicine to Chicago

BELLEVUE, Wash., Sept. 24 /PRNewswire/ — MD2 International, the pioneer of concierge medicine, opened a Chicago practice with two of the area’s finest primary care physicians. With 30 Fortune 500 companies in the metro area alone, Chicago was a natural choice for the company to seek its next two physicians and expand its network.

“Many of the families that we care for are taken care of in every aspect of their lives, from their finances, to their homes to staying at the Four Seasons,” said Peter Hoedemaker, CEO. “They can acquire the highest quality wherever they go, and they want that same quality and experience with their healthcare. Part of our expertise is providing care in a way that meets that need. We’re proud to bring that to Chicago with two of the most distinguished physicians in the nation.”

MD2’s high touch medicine combines passionate personal care with the superior expertise of two leading physicians. MD2 selected Drs. Steven Gallo and Joseph J. Hennessy after a rigorous search for the most noted practitioners in the area. They have more than 15 years experience respectively and join eight other MD2 physicians nationwide who care for 50 families each. Focusing on a smaller group of families, versus the 3,000 – 6,000 patients seen annually by many primary care physicians, enables them to provide highly attentive care in a private and comfortable setting.

“Our physician becomes your personal doctor,” said Mr. Hoedemaker. “They have the time to accompany you to the specialist or to meet you at the ER if needed. Because they are only caring for 50 families, they are with you every step of the way.”

MD2 only opens a new office when it has found the “doctor’s doctor,” the unique internist who is a pillar in their community. All MD2 physicians have about 15 – 20 years experience, strong ties to the hospitals and specialists in their cities, and are able to facilitate care for their families. In addition, all MD2 offices have private entrances and are designed to eliminate the traditional waiting room experience.

MD2 anticipates having about 15 offices around the nation in metropolitan cities with world-class hospitals.

   The Chicago office is located on the Magnificent Mile.    About the MD2 Chicago Physicians  

Dr. Hennessy is a native of Chicago, where he has provided primary care to many of his esteemed colleagues and prominent community members for over two decades. In addition to being an Assistant Professor and Senior Attending physician at Rush University Medical Center, he has been a Chicago White Sox Team physician since 2004. Dr. Hennessy is currently the Associate Director, Section of Internal Medicine at Rush and will continue his strong affiliation with the hospital.

Dr. Gallo is widely recognized for his exemplary and compassionate care, as well as for his mentoring and teaching abilities. As a medical student, he received the honor of being inducted into Alpha Omega Alpha in his third rather than fourth year, foreshadowing his future accomplishments. The recipient of numerous teaching awards, he is an Assistant Professor of Medicine at Northwestern University Medical School, where he has been teaching since 1994. He also teaches Medical Decision Making at the Feinberg School of Medicine.

About MD2. MD2 was founded by Dr. Howard Maron in 1996 and is credited as being the first concierge or retainer-based medical practice in the nation. The privately held company has offices in Seattle and Bellevue, Washington; Portland, Oregon; San Francisco and Chicago, and plans to grow nationwide to metropolitan cities with top-tier medical institutions. Each office has two highly accomplished and seasoned physicians who care for only 50 families each. http://www.md2.com/.

MD2 International

CONTACT: Diane Geurts of MD2 International, +1-206-769-8148

Web site: http://www.md2.com/

The American Diabetes Association and Gloria Gaynor Invite New Yorkers to ‘Step Out To Fight Diabetes’ on October 26th

NEW YORK, Sept. 24 /PRNewswire/ — The American Diabetes Association and Spokesperson, Grammy winning Gloria Gaynor, invite New Yorkers to Step Out to Fight Diabetes on Sunday, October 26, 2008. This walk will raise awareness and money for diabetes research and education. There are nearly 24 million Americans with diabetes and in the last 10 Years the numbers of New Yorkers who’ve been diagnosed with diabetes have increased by 250% and the death rate has nearly doubled. Gaynor, who will perform, is a long time advocate of the disease. “Diabetes is an awful, life-threatening disease that affects us all, I too have been personally affected by this disease,” said Gloria. “It’s such a rewarding experience to help fight for this important cause. I urge everyone to help by either walking or sponsoring a walker. Together, we can find a way to stop this tragedy.”

Funds raised will support of the Association’s mission: to prevent and cure diabetes and to improve the lives of all people affected by diabetes. Diabetes is the fifth deadliest disease in America, killing more people than AIDS or breast cancer. Nearly 6.2 million people are unaware that they have the disease and the numbers are rising by the minute. Because of these reasons, New Yorkers must take a forceful stance against this non-discriminating disease and unify as a community to end the rise and current conditions of Diabetes.

The walk will be on Sunday, October 26th at the South Street Southport in New York City. Participants will join last years 2,500 walkers, in effort to increase 2007’s donations of $470,000.00. Step-Out NYC not only educates, promotes exercise and activity but also entertains individuals, families and teams all day long, with giveaways, performances, on-site festivities, and a youth activity area. Check-in begins at 8:30 a.m. at the Seaport and the walk begins at 10 a.m. Gloria Gaynor’s performance featuring her worldwide hit “I will survive” will kick off the opening ceremonies at 9:00am.

To register, volunteer or find out more information, please visit diabetes.org/stepout or contact Antonio Coppola of the American Diabetes Association at (212) 725-4925 or [email protected]

Media Contact: Gwen Wunderlich-Smith, [email protected], or Melissa Charles, [email protected], +1-212-586-2240, both of FYI PR, for American Diabetes Association

American Diabetes Association

CONTACT: Gwen Wunderlich-Smith, [email protected], or Melissa Charles,[email protected], +1-212-586-2240, both of FYI PR, for American DiabetesAssociation

Web Site: http://diabetes.org/stepout

Grameen Health to Establish Independent Collaborations With Pfizer, GE Healthcare, and Mayo Clinic to Create Sustainable Healthcare Delivery Models for the Developing World

Grameen Health, an affiliate of Grameen Bank, the pioneering micro-financing organization in Bangladesh that shared the Nobel Peace Prize in 2006 for its work to alleviate poverty, announced today that it will establish independent partnerships with Pfizer Inc., GE Healthcare, and Mayo Clinic to create sustainable models for healthcare delivery in the developing world.

Grameen Health has chosen to work independently with these partners because of their respective expertise: Pfizer Inc is the world’s largest research-based pharmaceutical company, GE Healthcare is the world’s largest manufacturer of medical devices such as ultrasound and CT/MRI, and Mayo Clinic is the world’s first and largest integrated, not-for-profit group practice.

These multiple, independent collaborations will focus on social business models in which the businesses are self-supporting and any profits are re-invested into the system in order to reach more of the poor. This approach is cost-effective and maximizes the benefits that patients receive. The models will be transferable to other healthcare delivery systems.

According to the World Health Organization (WHO), among the biggest obstacles to improved health outcomes are inadequate health delivery and financing mechanisms that place the heaviest burden on the poor and sick, who are the least able to pay.

The independent collaborations will initially explore and evaluate ways to improve the existing Grameen Health delivery and financing systems in Bangladesh, with the aim of creating models that can be adapted for the needs of the 4 billion people around the world whose annual income is less than $3,000.

“As we address the challenges of global health access, we are pleased to partner with these and other organizations that share our belief that solutions to improving access to medicines and healthcare can be socially responsible and sustainable, yet commercially viable,” said Professor Muhammad Yunus, who shared the 2006 Nobel Peace Prize with Grameen Bank, which he founded and now directs. “In Bangladesh, we have found that only an economically viable solution can create the infrastructure needed to enable people to sustain themselves, alleviating the poverty cycle. We believe our knowledge and expertise in micro-financing can be applied toward the development of a sustainable health care system.”

During the next year, the collaborations will focus on the following areas:

— Implementing primary health promotion and disease prevention programs. These are the most cost-effective steps in affordable health care, and include maternal and child health promotion and nutrition programs.

— Analyzing ways to expand and improve the current low-cost micro-health delivery and insurance programs at Grameen Health’s 38 existing Kalyan clinics.

— Developing continuous training programs for nurses, technicians and physicians.

— Reviewing operating efficiencies and scope of services (e.g., telemedicine, mobile health care) at Grameen Health’s Kalyan clinics.

— Introducing genomic, epidemiological, and outcomes research capability for the prevention and treatment of diseases relevant to the population in Bangladesh, with an emphasis on the best use of existing tested and approved procedures and drugs.

Grameen Health and its partners hope to develop appropriate and sustainable models for healthcare delivery and rural primary care clinics, with the goal of replicating these models in other countries. Pfizer is dedicating key employees to provide technical and advisory support to evaluate Grameen’s existing healthcare delivery systems in Bangladesh. GE Healthcare will test delivery of ultrasound capability in rural clinics for early detection of abnormalities, and Mayo Clinic will work to improve the training, efficiency, and retention of staff at existing Grameen Health Kalyan clinics.

“Pfizer is honored to work with Grameen to explore the development of nonconventional, efficient and sustainable health financing and delivery models. We believe Grameen’s world-renowned success in providing innovative financial solutions for the poor, coupled with Pfizer’s health care experience, human capital and extensive arsenal of medicines, has the potential to improve the lives of millions of patients,” said Jean-Michel Halfon, Area President of Canada, Latin America, Africa, and Middle East pharmaceutical operations, Pfizer Inc.

“GE Healthcare is committed to early health initiatives,” said Omar Ishrak, President and Chief Executive Officer, Clinical Systems, GE Healthcare. “We have affordable technology with advanced imaging and care capabilities that can make a difference to save lives. With the ubiquitous usage of ultrasound, GE believes it’s provided a crucial tool in the early care of expectant mothers. We intend to work with Grameen Health to further understand and expand ultrasound usage in rural areas. Through this pilot program we plan to train providers in the usage of ultrasound, evaluate the product, the training and the workflow that would be needed to enable the full deployment of this technology. This is one positive step towards accessible and sustainable healthcare for the developing world.”

“Mayo Clinic and Grameen are exploring opportunities where our organizations can work collaboratively based on the junction of our missions and strategic priorities,” said Denis Cortese, M.D., president & CEO, Mayo Clinic. “These opportunities range from new methods of delivering care and dissemination of knowledge and best practices to education, clinical research and the use of new technology in non-traditional settings. Our two organizations are working diligently to find the opportunities that will have the best likelihood of improving health care delivery in developing countries.”

Professor Yunus adds: “Improving health care access and quality worldwide is a huge and long-term project. We would like to invite other partners and thought leaders to join in on the collaboration with Grameen Health, or to create their own social health care business models and share the results with us.”

About Pfizer

Pfizer is the world’s largest research-based biomedical and pharmaceutical company, with 85,000 colleagues operating in more than 150 countries. According to the World Health Organization (WHO), nearly one-third of the molecules on its “Essential Medicines List” are Pfizer medicines. For more information about Pfizer, visit www.pfizer.com.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that help clinicians around the world with new ways to predict, diagnose, inform and treat disease. GE Healthcare’s broad range of products and services enables health care providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. GE Healthcare’s vision is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. For more information about GE Healthcare, visit www.gehealthcare.com

About Mayo Clinic

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 “patient first” philosophy. 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. For more information about Mayo Clinic, visit www.mayoclinic.com

About Grameen Health

Grameen Health (GH) aims to extend the success of the microfinance model to health care by designing and developing a bottom-up health care infrastructure built from sustainable best practices in a broad range of health care services around the world, and improving upon them to deliver the highest quality health care in an efficient and sustainable manner for a broad market, including the poorest of the poor. GH will enable the poor to be self sufficient in addressing their health care needs such that they can accept, but not require, outside assistance.

GH will be a nation-wide healthcare service for all people, but particularly focused on the poor women and children. Just as Grameen Bank brought financial services at an affordable price to poor women, GH will aim to bring state-of-the-art health services to all people — particularly poor women and children. GH is in discussion with some of the world’s leading health providers. In addition to Mayo Clinic, GE Healthcare and Pfizer, Grameen is working on plans for collaborations with Massachusetts General Hospital, John Hopkins Hospital of the USA, Narayana Hrudayalaya of India, Johnson and Johnson, Bayer, BASF, Aga Khan University, and others.

This initiative will lead to the creation of a world class medical college and hospital, specialized hospitals, research centers in a 200 acre Health City, a series of nursing colleges, training programs for technicians, second tier hospitals, and rural health management centers throughout the country. Each rural health management center will be dedicated to improving and maintaining the health status of the people in its region, particularly focused on the poor women and children. These centers will be IT-linked with the Health City in Dhaka for continuous attention by specialist doctors and nurses. Through the nursing colleges, GH will train Bangladeshis — particularly the newly educated class of Grameen borrowers’ daughters — to choose nursing as a profession and to serve in Bangladesh and abroad.

InterMune to Present Four Abstracts on HCV Protease Inhibitor ITMN-191 at the AASLD Meeting

BRISBANE, Calif., Sept. 24 /PRNewswire-FirstCall/ — InterMune, Inc. today announced that four abstracts from clinical and in-vitro studies of ITMN-191 (R7227) accepted for presentation at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD, Oct. 31 – Nov. 4 in San Francisco), may now be viewed at http://www.aasld.org/. ITMN-191 is a hepatitis C virus (HCV) NS3 protease inhibitor, currently in a Phase 1b clinical trial in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin). The compound is being developed in collaboration with Roche.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, “Collectively, these abstracts demonstrate that in the experiments conducted, ITMN-191 was safe and very well tolerated in humans and demonstrated viral kinetics that are competitive with other direct anti-viral compounds in development. The safety and viral kinetic profile of ITMN-191 was observed in mono-therapy regimens administered twice-a-day and three-times-a-day in both treatment-naive patients and in patients who had failed to adequately respond to standard-of-care treatment. Additionally, results from in-vitro experiments of the antiviral effect of ITMN-191 in combination with two separate HCV polymerase inhibitors in the Roche portfolio suggest the potential benefit of treatment regimens that simultaneously target the HCV protease and polymerase.”

Results of Two Clinical Studies of ITMN-191

— A Phase 1a Single-Ascending-Dose (SAD) Study in Healthy Volunteers (Poster #1871): ITMN-191 was safe and well tolerated when given as a single dose to healthy adults in a range of doses from 2mg to 1600mg. Adverse events were generally mild and transient and were similar between treatment groups, with the exception of a higher frequency of mild and transient diarrhea and abdominal pain in the ITMN-191 group at the highest tested dose (1600mg). The pharmacokinetics of ITMN-191 were linear over the dose range of 100mg to 800mg. Co-administration of ITMN-191 with food increased the expected trough and AUC by 40-50% compared with administration of ITMN-191 without food. This “food effect” enabled InterMune and Roche to explore a lower range of doses of ITMN-191 in subsequent clinical studies than was previously planned.

— A Phase 1b Monotherapy Multiple-Ascending-Dose (MAD) Study in HCV Genotype 1 Patients (Poster #1847): ITMN-191 was administered as mono-therapy for 14 days to four cohorts of treatment-naive patients infected with HCV genotype 1. Multiple ascending doses were examined up to a total daily dose of 600mg. The safety and tolerability of ITMN-191 were excellent. Adverse events were generally mild and transient, with no evidence of clinically significant laboratory abnormalities or ECG changes. When ITMN-191 was administered every eight or twelve hours, viral kinetic results were very competitive with those of other direct antiviral compounds studied in similar experiments.

The MAD study also included one exploratory cohort of ITMN-191 given as mono-therapy for 14 days to strictly defined non-responders: HCV genotype 1 patients who had failed to achieve a 2.0 log10 reduction in HCV RNA with prior standard-of-care treatment, or who still had detectable HCV RNA after 24 weeks of treatment. At the one dose studied of 300mg given every 12 hours, ITMN-191 delivered a median reduction of HCV RNA at study day 14 of 2.5 log10. The results from this initial exploratory cohort in non-responders encouraged InterMune and Roche to continue their plans to aggressively study ITMN-191 in this difficult to treat population and provided an important insight to the range of doses to explore in future studies.

— Pharmacokinetic (pk) and Pharmacodynamic (pd) Results in the Phase 1b MAD Study (Poster #1861): ITMN-191 was intentionally designed to achieve a high liver-to-plasma ratio in HCV patients in order to reduce any potential side effects associated with systemic circulation of drug. Poster #1861 shows that the strong viral kinetic results reported in abstract #1847 were associated with very low plasma concentrations, achieving the key objective of a high liver-to-plasma ratio in patients infected with HCV. The pharmacokinetics of ITMN-191 in mono-therapy were more than dose proportional at higher doses.

Results of In Vitro Combinations of ITMN-191 plus direct anti-virals in HCV models

— Two Experiments of the Combination of ITMN-191 with HCV Polymerase Inhibitors R7128 and R1626 (Poster #1885): ITMN-191 was combined separately with two polymerase inhibitors, R7128 (Roche/Pharmasset) and R1626 (Roche) in two assays. One assay modeled HCV replication (14-day replicon clearance assay) and the other assay modeled viral resistance (a 3-week colony formation assay model). The combination of ITMN-191 with the active moeity of either R7128 or R1626 resulted in significantly enhanced clearance of the HCV replicon and reduced or suppressed the emergence of drug-resistant viral variants.

This work was carried out in anticipation of future clinical studies using ITMN-191 with either R7128 or R1626, and demonstrates that such combinations would likely result in significantly greater antiviral activity than has been observed with any of these agents in previous monotherapy trials.

Current Development of ITMN-191

Based on the encouraging results reported in the above studies, in late May 2008 InterMune initiated an ongoing 14-day study of ITMN-191 in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin). The study is exploring doses of ITMN-191 that were studied in mono-therapy (up to 600mg daily) and is also exploring higher doses. The study is meeting the companies’ expectations. Top-line results from the triple combination study are anticipated to be released in the fourth quarter of 2008.

InterMune’s ITMN-191 Presentations at AASLD

Titles of the InterMune posters to be presented at AASLD regarding the ITMN-191 development program are as follows:

Poster #1871: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of the NS3/4A Protease Inhibitor ITMN-191 in Healthy Subjects

Poster #1847: Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Patients with the NS3/4A Protease Inhibitor ITMN-191 Leads to Rapid Reductions in Plasma HCV RNA: Results of a Phase 1b Multiple Ascending Dose (MAD) Study

Poster #1861: Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships for ITMN-191 in a Phase 1 Multiple Ascending Dose (MAD) Trial in Patients with Genotype 1 Chronic Hepatitis C (CHC) Infection

Poster #1885: Combination of the NS3/4A Protease Inhibitor ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors R1626 or R7128 Enhances Replicon Clearance and Reduces the Emergence of Drug Resistant Variants

About AASLD

The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. The organization advances the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com/.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune’s judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune’s actual results could differ materially from those described in InterMune’s forward-looking statements.

Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading “Risk Factors” in InterMune’s most recent annual report on Form 10-K filed with the SEC on March 14, 2008 (the “Form 10-K”) and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune’s other periodic reports filed with the SEC, all of which are available via InterMune’s web site at http://www.intermune.com/.

Pegasys(R) and Copegus(R) are registered trademarks of Roche.

InterMune, Inc.

CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228,[email protected]

Web site: http://www.intermune.com/

In Vivo Characterization of Proliferation for Discriminating Cancer From Pancreatic Pseudotumors

By Herrmann, Ken Eckel, Florian; Schmidt, Stefan; Scheidhauer, Klemens; Krause, Bernd Joachim; Kleeff, Joerg; Schuster, Tibor; Wester, Hans- Juergen; Friess, Helmut; Schmid, Roland M; Schwaiger, Markus; Buck, Andreas K

We have determined the ability of PET with the thymidine analog 3′-deoxy-3′-^sup 18^F-fluorothymidine (FLT) to detect pancreatic cancer and to differentiate malignant from benign pancreatic lesions. Methods: In this prospective study, ^sup 18^F-FLT PET was performed on 31 patients with undefined pancreatic lesions. Routine diagnostic procedures included endoscopic ultrasound, MRI, or multislice helical CT of the upper gastrointestinal tract in all patients. Uptake of ^sup 18^F-FLT was evaluated semiquantitatively by calculation of mean and maximal standardized uptake values (SUVs). Results were correlated to the reference methods, which were histopathology (23/31) or cytology/clinical follow-up (8/31). Results: All 10 benign pancreatic lesions were negative on ^sup 18^F- FLT PET and showed only background activity (specificity, 100%; 90% confidence interval, 74%-100%). On visual interpretation, 15 of 21 malignant tumors presented as focal ^sup 18^F-FLT uptake higher than the surrounding background (sensitivity, 71.4%; 90% confidence interval, 52%-89%). ^sup 18^F-FLT PET missed 4 well-differentiated and 2 T1 cancers. Mean ^sup 18^F-FLT uptake was 3.1 in all malignant tumors (median, 2.8; range, 1.3-6.5), 3.7 in tumors with visual tracer uptake (median, 3.2; range, 2.1-8.5), and significantly higher in malignant than in benign tumors (mean/median, 1.4; range, 1.2-1.7; P

J Nucl Med 2008; 49:1437-1444

DOI: 10.2967/jnumed.108.052027

Chronic pancreatitis (CP) is considered one of the risk factors for the development of pancreatic ductal adenocarcinoma. Differentiating between pseudotumoral masses resulting from CP and pancreatic carcinoma can be clinically challenging because the two have similar imaging features and clinical presentations. To date, no single diagnostic approach is considered ideal for differentiating between pancreatic cancer and pseudotumoral CP (1). Several overlapping morphologic features of CP and pancreatic carcinoma contribute to and explain the limitations in differential diagnosis (2). CT examination is limited in identifying the ductal adenocarcinoma that begins during CP because of the reduced difference in density between the cancerous lesion, which is typically hypovascularized, and the pancreatic parenchyma, which is also typically hypovascularized in CP because of fibrosis (3). Up to 6% of the cases suspected to be malignant have been found to be benign at surgery, which may be associated with a postsurgical complication rate of up to 21% (4). Endoscopie ultrasound (EUS) has become the most accurate modality for the characterization, locoregional staging, and sampling of pancreatic lesions. EUS- guided fine-needle aspiration of suggestive tumors significantly improves the diagnostic reliability of EUS and should be regarded as the first choice for diagnosis in this setting. However, the improved sensitivity of EUS-guided fine-needle aspiration was only 73% in 1 trial (7), indicating that the diagnosis of evolving carcinoma in the background of CP remains difficult.

PET with the glucose analog ^sup 18^F-FDG is highly sensitive for detecting pancreatic cancer. However, ^sup 18^F-FDG also accumulates in inflammatory lesions (5). Therefore, discrimination of benign from malignant pancreatic masses with ^sup 18^F-FDG PET is problematic. The thymidine analog 3′-deoxy-3′-^sup 18^F- fluorothymidine (FLT) is a new radiopharmaceutical for clinical PET that specifically visualizes proliferating tissues (6,7). In the present study, we aimed to determine whether ^sup 18^F-FLT PET is adequate for detection of pancreatic cancer and differentiation of cancer from benign pancreatic lesions such as mass-forming pancreatitis.

MATERIALS AND METHODS

Patient Population

Thirty-one patients with a clinical suspicion of malignant pancreatic disease were included in this prospective study (22 men and 9 women; mean age, 61 +- 13 y; range, 39-79 y). Patients were recruited in the outpatient clinic of the Department of Internal Medicine II (gastroenterology) or the Department of General Surgery at Technische Universitat Munchen. Most patients were referred to our hospital for a further diagnostic work-up because of a new onset of jaundice or pain in the upper abdomen. Inclusion criteria comprised an initial diagnosis of a suggestive pancreatic tumor, diagnosed either by ultrasound, EUS, MRI, multislice helical CT, endoscopic retrograde cholangiopancreatography, or a combination of these. Patients with a history of CP and a new onset of extrahepatic biliary obstruction or increasing tumor markers CA 19-9 or CEA were also included.

Staging procedures included abdominal ultrasound, endoscopic retrograde cholangiopancreatography, EUS, MRI, or multislice CT of the chest and abdomen as clinically appropriate. Histologie or cytologie confirmation was obtained in most patients (23/31 and 5/ 31 patients, respectively). In cases of negative histologie or cytologie findings, EUS-guided fine-needle aspiration and biopsy or brushing of the distal bile duct was performed during follow-up. Informed consent was obtained from all patients. The study protocol was approved by the local ethics committee of Technische Universitat Munchen.

^sup 18^F-FLT PET

^sup 18^F-FLT was synthesized as previously described (8). Imaging was performed on a whole-body PET scanner (ECAT HR+; Siemens/ CTI). This scanner simultaneously acquires 47 contiguous slices with a slice thickness of 3.4 mm. The in-plane image resolution of transaxial images was approximately 8 mm in full width at half maximum, with an axial resolution of approximately 5 mm in full width at half maximum. Static emission images were acquired 45 min after injection of approximately 300 MBq of ^sup 18^F-FLT (range, 270-340 MBq). 18F-FLT PET was performed from the thorax to the pelvis (4-5 bed positions) for all patients. The duration was 8 min per bed position for emission scanning and 5 min for transmission scanning. Emission data were corrected for random coincidences, dead time, and attenuation and were reconstructed by filtered backprojection (Hanning filter with a cutoff frequency of 0.4 cycles per bin). The matrix size was 128 x 128 pixels, with a pixel size of 4.0 x 4.0 mm. The image pixel counts were calibrated to activity concentrations (Bq/mL) and decay-corrected using the time of tracer injection as the reference.

PET Data Analysis

All ^sup 18^F-FLT PET scans were evaluated by 2 experienced nuclear medicine physicians who were unaware of the clinical data and the results of other imaging studies. Any focally increased ^sup 18^F-FLT uptake in the upper abdomen was interpreted as malignant. Side-byside reading with a recent multislice CT scan of the abdomen was performed to ensure that increased ^sup 18^F-FLT uptake belonged to pancreatic tissue. When results between the 2 readers differed, they reached a consensus.

Circular regions of interest with a diameter of 1.5 cm were placed in the area with the highest tumor activity as described earlier (9). Mean and maximal standardized uptake values (SUVs) were calculated from each region of interest using the following formula: SUV = measured activity concentration (Bq/g) x body weight (g)/ injected activity (Bq). For definition of regions of interest and data analysis, computer programs have been developed in the Interactive Data Language (IDL; Research Systems, Inc.) using the Clinical Application Programming Package (CAPP; Siemens/CTI) (70).

Reference Methods for Assessment of Malignancy

In most patients (19/21), histopathology served as the reference for malignancy. Two cancer patients had the typical imaging findings of a pancreatic mass and liver metastases, indirectly demonstrating malignancy of the pancreatic tumor (patients 1 and 30). In patients from whom no specimen could be obtained, the diagnosis of CP was based on a combination of imaging methods such as multislice CT, EUS, and endoscopie retrograde cholangiopancreatography, which were repeated in due course. After patient recruitment began in April 2006, no malignant pancreatic tumor was diagnosed in patients with CP.

Statistical Analysis

Statistical analyses were performed using SPSS software (version 15.0; SPSS, Inc.). Quantitative values were expressed as mean +- SD, median, and range. Related metric measurements were compared using the Wilcoxon signed rank test and the Mann-Whitney U test in cases of 2 independent samples. Fisher exact tests were used for comparison of frequencies, and Spearman correlation coefficients were calculated to quantify bivariate correlations of measurement data. Exact 90% confidence intervals were reported for estimates of sensitivity and specificity. Receiveroperating-characteristic analysis was performed using SPSS software. All analyses were 2- sided and were performed at a 5% level of significance. RESULTS

Patients with Malignant Pancreatic Lesions

Twenty-one of the 31 patients turned out to have pancreatic cancer (Fig. 1). Detailed tumor characteristics are listed in Table 1. Malignancy of the pancreatic tumor was confirmed histologically in 19 patients. In 1 patient, MRI and contrastenhanced CT showed a typical finding of multiple liver metastases. Consequently, histologie verification of the pancreatic tumor was not performed. The second patient refused to have surgery or biopsy of the pancreatic tumor; however, the clinical course (rising level of tumor marker CA 19-9 and new onset of liver lesions on MRI and multislice CT) indicated malignant pancreatic disease. The histologic subtypes were adenocarcinoma (n = 15), cystadenocarcinoma (n = 1), squamous cell carcinoma (n = I), neuroendocrine carcinoma (n = 1), and undifferentiated carcinoma (n = 1). Fifteen tumors were in the head of the pancreas, 4 in the pancreatic corpus, and 2 in the tail of the pancreas (Table 1 ). Eight patients underwent complete surgical resection of the primary tumor. Seven patients had liver metastases, which were unresectable in 4 because of locally advanced disease. Of the latter, 1 patient died from thromboembolic complications during follow-up. In this patient, postmortem evaluation revealed stage 2b disease (American Joint Committee on Cancer staging system).

FIGURE 1. Scatter plot of mean ^sup 18^F-FLT SUV in pancreatic cancer with focal ^sup 18^F-FLT uptake (PET-positive), in pancreatic cancer negative on visual interpretation (PET-negative), and in benign pancreatic lesions (PET-negative). MFP = mass-forming pancreatitis; PC = pancreatic cancer.

Patients with Inflammatory Lesions

Of 10 patients in whom the reference methods indicated benign disease (Fig. 1), 4 underwent surgical bypass or resection, and the benign nature of the pancreatic mass was proven histologically (Table 1). In a further 5 patients with pancreatic masses, biopsies of the pancreas, distal bile duct, or duodenum failed to demonstrate malignant disease. EUS or endoscopic retrograde cholangiopancreatography was performed in 7 and 5 patients, respectively, and was repeated at least once to exclude false- negative results in 5 and 4 patients, respectively. To date, there has been no evidence of malignant disease in this patient subgroup.

Imaging Malignant Pancreatic Tumors with ^sup 18^F-FLT PET

^sup 18^F-FLT PET produced high-contrast images of proliferating structures (Fig. 2). Fifteen of 21 patients with malignant tumors presented with focal ^sup 18^F-FLT uptake higher than surrounding background activity (sensitivity of ^sup 18^F-FLT PET, 71.4%; confidence interval, 52%-89%). By visual interpretation, 6 tumors did not show focally increased tracer uptake, compared with the surrounding normal background activity (Tables 1-3; Fig. 3). The mean ^sup 18^F-FLT uptake in all malignant tumors was 3.1 (median, 2.8; range, 1.3-8.5; SD, 1.7). In PET-positive tumors, the mean ^sup 18^F-FLT uptake was 3.7 (median, 3.2; range, 2.1-8.5), being significantly higher than in PET-negative tumors (mean/median, 1.4; range, 1.21.7; P = 0.001 ) (Figs. 2 and 3; Table 2). The average maximal ^sup 18^F-FLTuptake in all malignant tumors was 3.7 (median, 3.5; range, 1.5-9.8). Mean maximal ^sup 18^F-FLT uptake was significantly higher in PET-positive tumors (4.4; median, 4.2; range, 2.6-9.8) than in PET-negative tumors (mean/median, 1.7; range, 1.5-2.0; P = 0.001).

The histology of the 6 pancreatic cancers negative on ^sup 18^F- FLT PET differed considerably from the ^sup 18^F-FLTpositive tumors. Most of the ^sup 18^F-FLT-negative tumors did not consist of the typical aggressive ductal subtype. There was 1 cystic adenocarcinoma, 2 tubular adenocarcinomas, and 1 poorly differentiated carcinoma not further classified. Most of these were of low tumor grade (1 grade I, 1 grade I-II, and 1 grade II). Furthermore, 2 of the ^sup 18^F-FLTnegative cancers were small tumors (clinical stage Tl with a size

Seven patients presented with liver metastases as indicated by MRI (3 patients) or helical CT (4 patients). One patient also had histologic verification of liver metastases. In 6 of these, ^sup 18^F-FLT showed reduced or absence of tracer uptake in corresponding lesions, compared with surrounding normal tissue. In another patient, metastatic sites presented as increased focal tracer uptake in the tumor margin, with a photopenic defect in the center of the lesion.

Imaging Benign Pancreatic Lesions with ^sup 18^F-FLT PET

All 10 patients in whom the reference methods indicated benign disease presented without focal tracer uptake (specificity, 100%; confidence interval, 74%-100%) (Tables 2 and 3). Mean ^sup 18^F-FLT SUV in benign pancreatic lesions was 1.4 (median, 1.4; range, 1.2- 1.7), being similar to background activity and significantly lower than in malignant lesions (P

Discriminating Cancer from Benign Pancreatic Lesions Using ^sup 18^F-FLT PET

Using visual interpretation criteria (focally increased ^sup 18^F- FLT uptake, compared with surrounding normal structures), the sensitivity, specificity, and accuracy of ^sup 18^F-FLT PET were 71.4% (15/21), 100% (10/10), and81% (25/31), respectively. Receiver- operating-characteristic analysis (Fig. 4) indicated a sensitivity of 81 %, a specificity of 100%, and an accuracy of 87%, with an area under the curve of 0.929 using a cutoff of 1.8 for mean ^sup 18^F- FLT SUV. Using maximal ^sup 18^F-FLT SUV, the same values (81%, 100%, and 87%) were calculated using a cutoff level of 2.1 for maximal ^sup 18^F-FLT SUV, with an area under the curve of 0.919.

TABLE 1

Tumor Characteristics, Lesion Location, ^sup 18^F-FLT PET Findings, Reference Method, and Clinical Consensus

DISCUSSION

Recently, the thymidine analog ^sup 18^F-FLT was suggested for noninvasive assessment of proliferation (11). In this pilot study, we demonstrated that PET with the in vivo proliferation marker ^sup 18^F-FLT is specific for malignant pancreatic tumors and may be used to noninvasively differentiate pancreatic cancer from pancreatic pseudotumors arising from CP. In our patient collective, all lesions that turned out to be of benign origin were negative on ^sup 18^F- FLT PET. Fifteen of 21 malignant tumors presented as focally increased tracer uptake, indicating a sensitivity of 71.4% for detecting malignant disease. Using a threshold of 1.8 for mean ^sup 18^F-FLT SUV, we found that sensitivity increased to 81% (maximal ^sup 18^F-FLT SUV, 2.1) and receiver-operating-characteristic analysis indicated an area under the curve of 0.93. Frequently, differential diagnosis of pancreatic tumors is challenging. Because of the high specificity, positive PET findings indicate cancer of the pancreas. ^sup 18^F-FLT PET may therefore aid in the decision- making process by further: ensuring the appropriateness of resective surgery.

When scan findings are negative, cancer cannot be excluded. ^sup 18^F-FLT-negative tumors turned out to differ significantly from PET- positive tumors regarding histologic subtype, tumor size, tumor grade, and clinical course. There were 2 Tl cancers, indicating a reduced sensitivity of ^sup 18^F-; FLT PET for detecting small primaries. A reduced sensitivity; for small pancreatic cancers has also been described for the standard radiotracer ^sup 18^F-FDG, presumably because of partialvolume effects (12). Moreover, tumor grade was low in most ^sup 18^F-FLT-negative tumors, and survival of these patients was favorable. Although a definite conclusion regarding a potential clinical role cannot yet be drawn, our pilot study suggests prognostic potential for ^sup 18^F-FLT PET and warrants evaluation in a larger series.

FIGURE 2. Spiral CT and ^sup 18^F-FLT PET of patient 21, with CP, and patient 23, with pancreatic cancer. Physiologically increased ^sup 18^F-FLT uptake is seen in bone marrow and liver, but only background activity of ^sup 18^F-FLT is seen in area of inflammatory pancreatic mass (true-negative). Focal ^sup 18^F-FLT uptake is seen in pancreatic carcinoma (true-positive).

With morphology-based imaging modalities such as CT, MRI, or EUS, differentiation of benign pancreatic tumors associated with CP and pancreatic adenocarcinoma remains problematic because of similar anatomic features. EUS has become the standard modality for the characterization of pancreatic tumors and locoregional staging of pancreatic cancer. EUS-guided fine-needle aspiration further improves the diagnostic reliability of EUS (1); however, because of sampling errors, diagnosis of early cancers arising from mass- forming pancreatitis remains difficult. A positive or negative ^sup 18^F-FLT PET scan may aid in the decision process if the clinical suspicion of pancreatic cancer is high and patients are potential candidates for surgical resection.

In principle, having a functional imaging test to complement standard diagnostic modalities would be advantageous. ^sup 18^F-FDG PET is now an accepted technology for differential diagnosis and staging of various cancers (13). In pancreatic cancer, ^sup 18^F- FDG PET has also been shown to be more accurate than other modalities but less specific when acute inflammation is present (14- 16). Expression of the glucose transporter-1 gene and membrane glucose transport is generally increased in pancreatic cancer but not in CP (17). In contrast, it has been shown that inflammatory cells such as neutrophils or activated macrophages avidly take up ^sup 18^F-FDG (18,19). Accordingly, ^sup 18^F-FDG has been reported to accumulate in various inflammatory processes (20,27), including acute pancreatitis (72). Therefore, Diederichs et al. (14) recommended excluding patients with evidence of acute-on-chronic pancreatitis by laboratory data to minimize false-positive PET findings. ^sup 18^F-FDG PET is also affected by other metabolic conditions such as altered glucose metabolism, causing a decreased sensitivity for detection of pancreatic cancer in patients with elevated plasma glucose levels (22,25). ^sup 18^F-FDG PET may also be inferior to MRI or spiral CT for detecting pancreatic cancer but is more accurate for detecting distant metastases (24-27). In a study by Heinrich et al., the sensitivity of combined ^sup 18^F-FDG PET/CT for detecting locoregional lymph node metastases was as low as 22%. However, in 5 of 59 patients with pancreatic cancer, previously unknown distant metastases were detected with ^sup 18^F- FDG PET/CT and surgery was avoided. This has led to a cost reduction of $63,000, indicating that the use of ^sup 18^F-FDG PET/CT may be cost-efficient despite the mentioned shortcomings (24). Even in the presence of inflammatory disease, ^sup 18^F-FDG PET may be helpful in detecting pancreatic cancer in patients with CP (27). However, the patient numbers are small, and the clinical role of PET for managing undefined pancreatic tumors or staging pancreatic cancer remains to be determined.

TABLE 2

^sup 18^F-FLT PET Findings, Using Visual Interpretation, Compared with Clinical Consensus

TABLE 3

^sup 18^F-FLT PET Findings, Using Cutoff of 1.8 for Mean SUV or 2.1 for Maximal SUV, Compared with Clinical Consensus

FIGURE 3. Spiral CT and ^sup 18^F-FLT PET of patient 18, with pancreatic cancer, and false-negative findings on ^sup 18^F-FLT PET. Physiologic ^sup 18^F-FLT uptake is seen in bone marrow and liver. Histology indicated T1 adenocarcinoma.

The use of integrated PET/CT scanners has been suggested for increasing the accuracy of PET. However, in 1 study, the sensitivity of PET/CT for detecting locoregional lymph node involvement was low whereas the sensitivity for distant metastases was acceptable (88%) (24). Specific imaging of proliferation using ^sup 18^F-FLT may overcome some of the limitations associated with ^sup 18^F-FDG. In a previous study, we demonstrated that ^sup 18^F-FDG uptake is similarly increased in CP and pancreatic adenocarcinoma. In contrast, tumor proliferation as determined by immunohistochemistry could better differentiate between benign and malignant pancreatic tumors than could altered glucose metabolism (5). The mean percentage of Ki-67-positive cells was about 10-fold higher in pancreatic cancer than in CP, indicating that proliferative activity is strongly elevated in pancreatic carcinoma but only slightly elevated in CP. For pancreatic tumors, tracers reflecting proliferative activity, such as ^sup 11^C-thymidine or ^sup 18^F- FLT (11), offer advantages over ^sup 18^F-FDG and may be more suitable for differentiating malignant from inflammatory processes. The operating expenses for synthesis of ^sup 18^F-FLT are similar to those for ^sup 18^F-FDG, further supporting its clinical application.

^sup 18^F-FLT turned out to be specific for pancreatic cancer; however, the major drawback of our series was a reduced sensitivity for malignant lesions. A similar reduction in sensitivity was found in a recent pilot study comprising 5 patients with pancreatic cancer (28) and in 2 larger series in lung cancer (6,29). Moreover, reduced detection rates of liver metastases have been described in colorectal cancer (30) and non-small cell lung cancer (31). In our series, liver metastases were present in 7 patients and predominantly appeared as areas of reduced tracer uptake, compared with surrounding normal tissue. Therefore, small liver metastases may also be missed in pancreatic cancer, impairing the potential of ^sup 18^F-FLT PET for tumor staging.

The rationale for the use of ^sup 18^F-FLT as a surrogate marker of cellular proliferation is based on its substrate specificity for the cell cycle-regulated protein thymidine kinase 1. Barthel et al. reported that in vivo uptake of ^sup 18^F-FLT is closely related to thymidine kinase 1 activity and the cellular concentration of adenosine triphosphate (32). However, ^sup 18^F-FLT acts as a chain terminator and is therefore not incorporated into DNA and represents no direct measure of proliferation (33). Perumal et al. showed that ^sup 18^F-FLT uptake is also related to the expression of nucleoside transporters (34). After treatment with inhibitors of thymidylate de novo synthesis such as 5-fluorouracil or methotrexate, a 7- to 10- fold increase in ^sup 18^F-FLT uptake was observed in esophageal carcinoma cells. This finding may be related to an activation of the thymidylate salvage pathway and a concomitant increase in thymidine kinase 1 activity (35). However, the detailed uptake mechanism of ^sup 18^F-FLT in various tumors remains to be determined, especially in pancreatic tumors.

FIGURE 4. Receiver-operating-characteristic analysis of ^sup 18^F- FLT PET for discriminating cancer from benign pancreatic lesions. Area under curve is 0.93 using cutoff of 1.8 for mean SUV or 0.92 using cutoff of 2.1 for maximal SUV.

Several limitations have to be considered when our results are transferred to the clinical situation. Our findings apply to a particular patient collective that did not cover all histologic subtypes of pancreatic tumors. Whereas most of the ^sup 18^F-FLT PET literature reports relatively specific uptake of ^sup 18^F-FLT in malignant tumors (6,7,30,36-39), nonspecific uptake in reactive cervical lymph nodes of patients with head and neck cancer has recently been described (40). An increased proliferation rate is not specific for malignant tumors, and thus, unspecific uptake of ^sup 18^F-FLT in reactive nodes or inflammatory pancreatic lesions cannot be excluded.

CONCLUSION

Focal uptake of the thymidine analog ^sup 18^F-FLT was observed exclusively in malignant pancreatic tumors, indicating a potential role in the differential diagnosis of undefined lesions. These promising results warrant analysis in a larger series that also evaluates the prognostic role of ^sup 18^F-FLT PET in pancreatic cancer.

ACKNOWLEDGMENTS

We appreciate the excellent contributions made by our colleagues Jens Stollfuss, Hans Hofler, Alexander Kroiss, Petra Watzlowik, Karin Kantke, and Michael Herz; the great support by Christine Praus; our students Barbara Nurnberger and Daniela Zwiesler; and our technical staff members Brigitte Dzewas and Coletta Kruschke. This work was supported by grant LSHC-CT-2004-503569 from EMIL (European Molecular Imaging Laboratories).

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10. Weber WA, Ziegler SI, Thodtmann R, Hanauske AR, Schwaiger M. Reproducibility of metabolic measurements in malignant tumors using FDG PET. J Nucl Med. 1999;40:1771-1777.

11. Shields AF, Grierson JR, Dohmen BM, et al. Imaging proliferation in vivo with (F-18]FLT and positron emission tomography. Nat Med. 1998;4:1334-1336.

12. Diederichs CG, Staib L, Vogel J, et al. Values and limitations of ^sup 18^F-fluorodeoxyglucose-positron-emission tomography with preoperative evaluation of patients with pancreatic masses. Pancreas. 2000;20:109-116.

13. Juweid ME, Stroobanis S, Hoekstra OS, et al. Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma. J Clin Oncol. 2007;25:571-578.

14. Diederichs CG, Staib L, Glasbrenner B, et al. F-18 fluorodeoxyglucose (FDG) and C-reaciive protein (CRP). Clin Positron Imaging. 1999;2:131-136.

15. Friess H, Langhans J, Ebert M, et al. Diagnosis of pancreatic cancer by 2[^sup 18^F]-fluoro-2-deoxy-D-glucose positron emission tomography. Gut. 1995;36: 771-777.

16. Shreve PD. Focal fluorine-18 fluorodeoxyglucose accumulation in inflammatory pancreatic disease. Eur J Nucl Med. 1998;25:259- 264. 17. Reske SN, Grillenberger KG, Glatting G, et al. Overexpression of glucose transporter 1 and increased FDG uptake in pancreatic carcinoma. J Nucl Med. 1997;38:1344-1348.

18. Jones HA, Clark RJ, Rhodes CG, Schofield JB, Krausz T, Haslett C. In vivo measurement of neutrophil activity in experimental lung inflammation. Am J Respir Crit Care Med. 1994;149:1635-1639.

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20. Guhlmann A, Brecht-Krauss D, Suger G, et al. Chronic osteomyelitis: detection with FDG PET and correlation with histopathologic findings. Radiology. 1998;206:749-754.

21. Tahara T, Ichiya Y, Kuwabara Y, et al. High [^sup 18^F]- fluorodeoxy glucose uptake in abdominal abscesses: a PET study. J Comput Assist Tomogr. 1989;13:829-831.

22. Bares R, Klever P, Hauptmann S, et al. F-18 fluorodeoxy glucose PET in vivo evaluation of pancreatic glucose metabolism for detection of pancreatic cancer. Radiology. 1994;192:79-86.

23. Diederichs CG, Staib L, Glatting G, Beger HG, Reske SN. FDG PET: elevated plasma glucose reduces both uptake and detection rate of pancreatic malignancies. J Nucl Med. 1998;39:1030-1033.

24. Heinrich S, Goerres GW, Schafer M, et al. Positron emission tomography/ computed tomography influences on the management of resectable pancreatic cancer and its cost-effectiveness. Ann Surg. 2005;242:235-243.

25. Ruf J, Lopez Hanninen E, Oettle H, et al. Detection of recurrent pancreatic cancer: comparison of FDG-PET with CT/MRI. Pancreatology. 2005;5:266-272.

26. Saisho H, Yamaguchi T. Diagnostic imaging for pancreatic cancer: computed tomography, magnetic resonance imaging, and positron emission tomography. Pancreas. 2004;28:273-278.

27. van Kouwen MC, Jansen JB, van Goor H, de Castro S, Oyen WJ, Drenth JP. FDG-PET is able to detect pancreatic carcinoma in chronic pancreatitis. Eur J Nucl Med Mol Imaging. 2005;32:399-404.

28. Quon A, Chang ST, Chin F, et al. Initial evaluation of ^sup 18^F-fluorothymidine (FLT) PET/CT scanning for primary pancreatic cancer. Eur J Nucl Med Mol Imaging. 2008;35:527-531.

29. Vesselle H, Grierson J, Muzi M, et al. In vivo validation of 3’deoxy-3′-[^sup 18^F]fluorothymidine ([^sup 18^F]FLT) as a proliferation imaging tracer in humans: correlation of [^sup 18^F]FLT uptake by positron emission tomography with Ki-67 immunohistochemistry and flow cytometry in human lung tumors. Clin Cancer Res. 2002;8:3315-3323.

30. Francis DL, Freeman A, Visvikis D, et al. In vivo imaging of cellular proliferation in colorectal cancer using positron emission tomography. Gut. 2003;52:1602-1606.

31. Buck AK, Hetzel M, Schimneister H, et al. Clinical relevance of imaging proliferative activity in lung nodules. Eur J Nucl Med Mot Imaging. 2005;32: 525-533.

32. Barthel H, Perumal M, Latigo J, et al. The uptake of 3′- deoxy-3′-[^sup 18^F]fluorothymidme into L5178Y tumours in vivo is dependent on thymidine kinase 1 protein levels. Eur J Nucl Med Mol Imaging. 2005;32:257-263.

33. Shields AF, Briston DA, Chandupalla S, et al. A simplified analysis of [^sup 18^F]3′-deoxy-3′-fluorothymidine metabolism and retention. Eur J Nucl Med Mot Imaging. 2005;32:1269-1275.

34. Perumal M, Pillai RG, Barthel H, et al. Redistribution of nucleoside transporters to the cell membrane provides a novel approach for imaging thymidylate synthase inhibition by positron emission tomography. Cancer Res. 2006;66:8558-8564.

35. Muzi M, Mankoff DA, Grierson JR, Wells JM, Vesselle H, Krohn KA. Kinetic modeling of 3′-deoxy-3′-fluorothymidine in somatic tumors: mathematical studies. J Nucl Med. 2005;46:371-380.

36. Buck AK, Bommer M, Stilgenbauer S, et al. Molecular imaging of proliferation in malignant lymphoma. Cancer Res. 2006;66:11055- 11061.

37. Cooper LS, Gillett CE, Smith P, Fentiman IS, Barnes DM. Cell proliferation measured by MIBI and timing of surgery for breast cancer. Br J Cancer. 1998;77:1502-1507.

38. Kenny LM, Vigushin DM, Al-Nahhas A, et al. Quantification of cellular proliferation in tumor and normal tissues of patients with breast cancer by [^sup 18^F]fluorothymidine-positron emission tomography imaging: evaluation of analytical methods. Cancer Res. 2005;65:10104-10112.

39. Pio BS, Park CK, Pietras R, et al. Usefulness of 3′-[F- 18]fluoro-3′-deoxythymidine with positron emission tomography in predicting breast cancer response to therapy. Mol Imaging Biol. 2006;8:36-42.

40. Troost EG, Vogel WV, Merkx MA, et al. ^sup 18^F-FLT PET does not discriminate between reactive and metastatic lymph nodes in primary head and neck cancer patients. J Nucl Med. 2007;48:726-735.

Ken Herrmann*1, Florian Eckel*2, Stefan Schmidt3, Klemens Scheidhauer1, Bernd Joachim Krause1, Joerg Kleeff4,

Tibor Schuster5, Hans-Juergen Wester1, Helmut Friess4, Roland M. Schmid2, Markus Schwaiger1, and Andreas K. Buck1

1 Department of Nuclear Mediane, Technische Universitat Munchen, Munich, Germany; 2 Department of Internal Medicine II, Technische

Universitat Munchen, Munich, Germany; 3 Department of Radiology, Technische Universitat Munchen, Munich, Germany; 4 Department

of Surgery, Technische Universitat Munchen, Munich, Germany; and 5 Department of Medical Statistics, Technische Universitat

Munchen, Munich, Germany

Received Apr. 26, 2008; revision accepted May 5, 2008.

For correspondence or reprints contact: Andreas K. Buck, Department of Nuclear Medicine, Technische Universitat Munchen, Ismaninger Strasse 22, D-81675 Munich, Germany

E-mail: [email protected]

* Contributed equally to this work.

COPYRIGHT (c) 2008 by the Society of Nuclear Medicine, Inc.

Copyright Society of Nuclear Medicine Sep 2008

(c) 2008 Journal of Nuclear Medicine, The. Provided by ProQuest LLC. All rights Reserved.

Big Bang Collider To Start Up In Spring

The massive particle collider built to simulate the conditions of the “Big Bang” will not restart until spring 2009 after a technical glitch forced its shutdown, according to the European Organization for Nuclear Research, or CERN.

Experts have been down into the 17-mile tunnel housing the Large Hadron Collider (LHC) to see what they could determine about the damage.

A helium leak into the tunnel housing, the biggest and most complex machine ever made, forced CERN to shut down its LHC Saturday, just 10 days after starting it up.

CERN Director-General Robert Aymar said this was a psychological blow after a successful start of the LHC following years of painstaking preparation by teams of scientists.

“I have no doubt that we will overcome this setback with the same degree of rigor and application,” he said in a statement.

CERN said they will still have to wait several weeks before the temperature can be raised from near absolute zero so that they can go inside the equipment to examine the extent of the damage, said spokesperson James Gillies.

“They’re going to have to open up and really investigate what went on there,” Gillies said. “So that’s going to be two or three weeks before we can put out something that we’re sure of.”

“The winter shutdown will go according to schedule, which means that we start up the accelerator complex in the spring months.”

Only then will the LHC be able to collide protons, revealing how the tiniest particles were first created after the “big bang.”

Both the investigation and repairs, followed by CERN’s winter maintenance period, will push back the restart of the accelerator complex to early spring 2009.

CERN will then resume sending beams of particles around the tunnel, then the next step is to smash beams traveling in opposite directions into each other at the speed of light.

That, said Gillies, “is something that we do every year and it’s something we have a lot of experience in doing, so there’s no reason to think that that would not go rather quickly. I suspect that the priority for the restart next year will be to get LHC beams as quickly as possible.”

The new collider was revealed September 10th, but a transformer failed about 36 hours after startup. However, that was a simple fix because it was outside the cold zone. The machine was ready to go again when the electrical fault occurred.

Scientists hope the powerful LHC will reveal more about “dark matter,” antimatter and possibly hidden dimensions of space and time.

Experts also want to find evidence of a hypothetical particle called the Higgs boson. It is sometimes called the “God particle” because it is believed to give mass to all other particles, and therefore to matter that makes up the universe.

Scientists once believed protons and neutrons were the smallest components of an atom’s nucleus, but experiments have shown that protons and neutrons are made of quarks and gluons and that there are other forces and particles.

Skeptics have expressed fears that the high-energy collision of protons could eventually imperil the Earth by creating micro black holes, which are subatomic versions of collapsed stars whose gravity is so strong they can suck in planets and other stars.

CERN, says there was never any risk to people from the malfunction, and maintain the project is safe.

On the Net:

ImmuneRegen Scientist to Present Viprovex(R) Pre-Clinical Study Findings at 2008 BARDA Industry Day

ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), will present pre-clinical study results that indicate that its drug candidate Viprovex(R) enhances the safety and efficacy of Tamiflu(R) (manufactured by Hoffmann-La Roche Inc.) in treating influenza at the 2008 Biomedical Advanced Research and Development Authority (BARDA) Industry Day. Heidi L. Pinyerd, scientific program manager at ImmuneRegen, will display findings in the poster entitled, “Viprovex Enhances Tamiflu Safety/Efficacy in Influenza A/H3N2 Exposed Cotton Rat” at 6 p.m., Sept. 24 and 25th, at the Crystal Gateway Marriott, Arlington, Va.

“Studies conducted by ImmuneRegen, Virion Systems, Inc. and PanFlu, LLC indicated that a combination of Viprovex and Tamiflu was more effective in treating viral infection with human influenza A/H3N2 in cotton rats compared to treatment with Tamiflu alone,” said Hal Siegel, Ph.D., ImmuneRegen’s vice president and chief scientific officer. “Results showed that Viprovex reduced the lung inflammation resulting from infection in cotton rats — the preferred small animal for studying influenza virus pathogenesis — while those treated only with Tamiflu experienced no reduction.”

Added Siegel, “The other key finding indicated that influenza-infected animals experienced infection-associated hypothermia and weight loss, but those administered Viprovex underwent substantial improvement. Good Laboratory Practice compliant safety studies are underway and our goal is that human clinical trials involving Viprovex will start in 2009.”

Studies also indicated that animals on the combined drug regimen had a lower mortality rate (7 percent) compared to those on Tamiflu alone (14 percent) while those that only received Viprovex all survived.

Viprovex is an intranasal drug candidate for potential use against infectious diseases as a vaccine adjuvant or as part of combination therapy. It is based on Homspera(R), ImmuneRegen’s adult stem cell active compound, which has shown in studies that it may function to regenerate and strengthen the immune system and enhance wound healing. Tamiflu is an antiviral drug approved by the U.S. Food and Drug Administration for the treatment and prevention of uncomplicated influenza in adults and children at least one year old. It has been taken by tens of millions of patients and stockpiled by governments worldwide. However, increasing reports of adverse events in children and viral resistance to Tamiflu have sparked concern about Tamiflu’s effectiveness against influenza.

The 2008 BARDA Industry Day provides an open forum for companies interested in working with the Federal Government to showcase technological advances in medical countermeasures to man-made and naturally occurring threats. Presenters will demonstrate the progress of current activities in advanced research and development of medical countermeasures that will contribute to the success of the U.S Health and Human Services Pandemic Influenza Plan, Project BioShield, BARDA, and the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan.

About Viprovex(R) and Homspera(R)

Viprovex is the trade name used that refers to formulations of Homspera for potential indications for treatment of viral and bacterial infections. Homspera is a generic name used by ImmuneRegen to describe the synthetic peptide Sar9, Met (O2)11-Substance P, an analog of the naturally occurring human neuropeptide Substance P, which can be found throughout the body, including in the airways of humans and many other species. All of ImmuneRegen’s research and development efforts are in the early, pre-clinical stage, and Homspera, as Viprovex, has undergone exploratory studies to evaluate its biological activity in small animals.

About ImmuneRegen BioSciences, Inc.

ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc., (OTCBB: IRBS), is a development-stage biotechnology company focused on the research, development and licensing of Homspera(R) and its derivatives. Homspera is an adult stem cell active compound that, in study results, has been shown that it may have effects on the regeneration and strengthening of the immune system and on enhancing wound healing. To advance its mission, the Scottsdale, Arizona-based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems, Inc. For more information, please visit www.immuneregen.com.

Statements about ImmuneRegen’s future expectations, including statements about the potential use and scientific results for ImmuneRegen’s drug candidates, science and technology, and all other statements in this press release other than historical facts, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen’s business, are subject to various risks and uncertainties. ImmuneRegen’s actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen’s periodic report on Form 10-Q for the three months ended June 30, 2008 and on Form 10-KSB for the year ended December 31, 2007 as filed with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen’s proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements.

 CONTACT:  Amendola Communications for ImmuneRegen www.acmarketingpr.com  Jan Shulman 480-664-8412 ext. 12 Email Contact  Jodi Amendola 480-664-8412 ext 11 Email Contact

SOURCE: ImmuneRegen BioSciences, Inc.

TAIC Wins $500m US Defense Contract

US-based IT and professional services company Technology Associates International Corporation (TAIC) has won a 10 year $500m contract from the US Marine Corps Systems Command for Commercial Enterprise Omnibus Support Services (CEOss) in the specialty engineering services domain.

Under the contract, TAIC will support the Marine Corps Systems Command in all aspects of acquisition, engineering, logistics, and technology. The contract will serve approximately 1,300 government customers across 24 technical offices.

The company has been providing program management, engineering, information assurance, Counter Improvised Explosive Device (CIED) assessment and analysis, acquisition logistics, and budget/financial management services to the US Marine Corps since 2004.

TAIC will lead a team of 18 subcontractors, including Northrop Grumman, BAE Systems, EG&G, and Booz Allen Hamilton. The majority of the work will be undertaken from its Stafford, Virginia, offices and on-site at the customer’s Quantico, Virginia, facilities.

Walt T. Oleski, president and chief executive at TAIC, said: “Technology Associates is honored to support Marine Corps Systems Command and its critical programs improving the security of the American warfighter. The team assembled in support of this vital mission emphasizes the quality of our employees and the resources they bring to bear.”

Pakistan to Set Up 10 Nuclear Power Plants

Text of report headlined “Pakistan to install 10 n-power plants” by Pakistani newspaper The News website on 24 September

[by Khalid Mustafa]

Islamabad: Pakistan will install 10 nuclear power plants in toto for which six sites have been selected to make possible “the mission impossible” to increase capacity to generate 8,800 MW of nuclear energy in over 22 years time, a senior government official told The News.

“The Pakistan Atomic Energy Commission (PAEC) has selected six sites on the basis of the Pakistan Nuclear Regulatory Authority (PNRA) and the International Atomic Energy Agency (IAEA).” According to a senior official, the PAEC have selected six sites for installation of more nuclear power plants (NPPs) that include 1) Qadirabad-Bulloki (QB) link canal near Qadirabad Headworks; 2) Dera Ghazi Khan (DG) canal near Tuansa barrage, 3) Taunsa-Punjnad (TP) canal near Multan; 4) Nara canal near Sukkur, 5) Pat Feeder canal near Guddu and 6) Kabul river near Nowshera.

These sites are in addition to the Chashma site where four nuclear plants will be installed. The other nuclear power plants would be installed at sites selected by the PAEC.””Objectives of the site selection are to determine all natural and man-induced hazards at a site which could jeopardise the safety of the NPP; reject a site if an engineering solution is not available to mitigate effects of any hazard and establish design-based parameters.

Under the strategy to achieve the target, Islamabad is to seek from Beijing the fuel technology for future nuclear power plants during the forthcoming visit of President Zardari to China that is to take place somewhere by the mid of next month.

“Pakistan that is going to install two more nuclear power plants at Chashma which are to be known as C-3 and C-4. These power plants will cost over 139bn rupees, including a foreign exchange component of 99.538bn rupees.”

The country has also planned to establish a nuclear power fuel complex (NPFC) at a cost of 51.298bn rupees to locally fabricate fuel that will be used for the future nuclear power plants in the country. The Nuclear Power Fuel Complex is under implementation that consists of five components that include Chemical Processing Plants, Enrichment Plant, Seamless Tube Plant-1; Fuel Fabrication Plant; and Nuclear Fuel Testing Plant.

To achieve the target, authorities concerned also made a plan to develop manpower to materialise the country’s nuclear power programme. “We have, to this effect, initiated a capacity building program of paramount importance at a cost of 491.42m rupees, including foreign exchange component of 166.70m rupees,” the official said.

The government needs trained and qualified professionals to collaborate in the design and construction of more nuclear power plants to generate 8,800 MW of electricity. “Practically, we need 200-300 professionals per plant and an overhead of 600-800 centrally placed professionals to participate in the project management, design, engineering construction and installation of the nuclear power plants.”

“The currently available manpower for this purpose is less than 150 persons.” To a question, the official said selected professionals would also be provided sufficient competency in Chinese language to enable them to communicate with vendors and manufacturers in China.

They would also be provided some on-the-job hands-on training in the Chinese nuclear industry especially those related to manufacturing. To a question, the official said the PAEC has planned to recruit 400 persons during the next five years at the rate of 80 persons per year and keep them under training for a period of 18-20 months.

“The training program of these persons will primarily consist of teaching them technical Chinese languages. And the services of NUML (National University of Modern Language) specialists will be used for this purpose.”

The official also disclosed that the said personnel would also be provided some nuclear power plants orientation and those who are not well-versed with Chinese language and in orientation courses will be sent for on-job training in China for up to four months depending upon their area of expertise and the availability of the training location.

Originally published by The News website, Islamabad, in English 24 Sep 08.

(c) 2008 BBC Monitoring South Asia. Provided by ProQuest LLC. All rights Reserved.

Macrosocial Determinants, Epidemiology, and Health Policy: Should Politics and Economics Be Banned From Social Determinants of Health Research?

By Muntaner, Carles Chung, Haejoo

In “Epidemiology and the Macrosocial Determinants of Health,” Putnam and Galea highlight important new developments in health policy and social epidemiology. We aim, in this commentary, to enhance the issues raised by the authors while complementing their arguments with our analyses. We agree that social epidemiologists interested in health policy might be drawn more often to macrosocial analysis because political forces and health policies affecting the public’s health tend to begin at the national level (i). Nevertheless, between holism (the focus on macrosocial factors and outcomes) and individualism or the microsocial analysis of common social epidemiology (e.g., social capital, education, personal income, occupation), there is a third option. This third option is systemism, which allows us to integrate macro- and micro-levels when policies demand it (z). Following Bunge’s postulates (3):

1. everything is a system or a component of a system;

2. systems have system level characteristics that their components lack (e.g., income inequality is a feature of society that a person does not have);

3. all problems need to be addressed in a systematic way rather than in a fragmented way (this is why social epidemiology rarely produces explanations as it follows the fragmented risk factor approach);

4. ideas should be put into systems (theories).

Thus, individualists study only the components of social systems (low-income persons, women), ignoring their structure (e.g., class relations, patriarchy). Macrosocial epidemiology will correct this lacuna as far as it embraces macro-micro analyses. A BoudonColeman diagram (3) illustrates the advantages of systemic thinking.

The macrosociologist might find it difficult to explain how economic growth leads to stagnation in, say, a contemporary wealthy country, and the individualist does not understand from where old age pensions originate (from a government’s political economy). Only the systemic view has a complete understanding of the social mechanisms linking macro- and micro-social levels.

Putnam and Galea are correct in acknowledging that the Social Determinants of Health (SDOH) approach broke with the microsocial dominance in epidemiology – social support, anger, isolation, John Henryism, Type A, job strain, life events, sense of coherence, educational attainment, occupational prestige, “SES,” among others. We hope that the WHO Commission on SDOH (4) will establish social epidemiology as an important field to be reckoned with in the future. We note, however, that models such as the “gradient” or the “fundamental causes” propose a grand generality that is often contradicted by historical context. In specific historical periods, for example, the wealthiest have been exposed to more risk factors than the poor – smoking, animal fat, and cocaine (5).

SDOH models still bear the imprimatur of physics, while their object of study might be closer to history or early evolutionary theory (6). Sociology may involve drawing strong conclusions from observations rather than experiments, summarizing vast amounts of data into relatively simple theories, favoring explanation over prediction (6). Thus, lack of macrosocial explanations also affects SDOH research, even in its most established findings: although, for example, there are hundreds of studies on income and health, very few of them consider income as endogenous to politics, governments, class conflict, unions, or other social institutions (7). Putnam and Galea are also right on the mark when they point to the avoidance of macrosocial studies in epidemiology (8). Already in the 19705, the studies of Harvey Brenner on macroeconomics and population health were received with controversy (9). They failed to capture the interest of epidemiologists. It took two decades for a rekindling of interest for Brenner’s macroeconomic models in epidemiology (10).

To clarify our models, we can divide macrosocial determinants of health into three categories: economic, political, and cultural (including science, technology, ideology, religion, etc.) (z). Thus a tax reduction on capital gains is political, income inequality is economic, and the belief in the collective benefits of private property is cultural. All are exogenous to microsocial factors (e.g., work organization, interpersonal violence, social support). Putnam and Galea astutely signal the lack of social mechanisms that follows from the neglect of macrosocial determinants. Yet some mechanisms are ignored even at the microlevel due to their controversial (political) nature. Class exploitation can be measured at the macro- (e.g., national), meso- (organizational), and micro- social levels (n). On the other hand, some macrosocial determinants that carefully bypass any political mechanism, such as social capital, have been enthusiastically embraced (12.).

Interestingly, Putnam and Galea trace adoption of multilevel models in social epidemiology to the theoretical and ethical critique of individualism in epidemiology and public health (13). Theory and values preceded the adoption of statistical techniques. As a coauthor (C.M.) of some of the first papers using this multilevel analysis in social epidemiology (14-16), I can bear witness that the emphasis on context by Nancy Krieger (with precedents in Engels and Sydenstryker among others) provided a powerful incentive to find the adequate statistical method to test contextual and multilevel hypotheses. As Putnam and Galea illustrate, the field of “macrosocial determinants of health” needs foundational conceptual work. Concepts are often confusing as sociopolitical and socioeconomic are redundant. Every economic or political fact is surely social. Eco-social would also be redundant, unless “eco” means the physical and biological environment of a society. Concepts are inadequate structural should refer to the relations among the components of a system and not to its level. Similarly, global is too restrictive; too idiosyncratic – societal; and metaphors abound – upstream, ultimate, macro.

The authors identify four barriers to explain why macrosocial determinants have been given so little attention in epidemiology. Yet, the definition of epidemiology as an applied science that studies the distribution and determinants of disease in populations implicitly includes macrosocial determinants. Populations are systems of persons defined not only by biological relations but also by social relations – political, economic, and cultural (17). Why then do epidemiologists want to restrict the scope of their discipline? Internal factors could be the biological training of the leadership of the discipline – dentistry, medicine, pharmacy, biology – or the controversy surrounding social science, policy, and politics in general, which can threaten the scientific status and funding of a discipline. External factors would involve, for example, the institutional linkages between epidemiology and medicine and the economics of biomedical research.

The supposed lack of objectivity of macrosocial science constitutes a second objection. Such concerns apparently do not stop macroeconomists from being among the most influential applied scientists of our time. For decades social scientists have studied objectively subjective social issues such as political ideology. They have transformed these soft sciences into hard technologies on which we all depend. In fact, the contemporary accuracy of predictions of electoral behavior, for example, is impressive.

The Weberian ethos of value free social science, fully endorsed by epidemiology, has hurt epidemiology by placing too many topics off limits for fear of not being objective. In applied science (epidemiology) and technology (public health), values are explicit since the goal of these disciplines is to change the world. Just as using firearms and tobacco are surely bad for health, a political system that generates poverty can also be considered bad for health. In fact, failing to declare policy preferences implies not fulfilling the epidemiologist’s role.

Another popular barrier involves the “ecological fallacy” or Robinson bias. Geoffrey Rose has put forward the case for macrosocial studies in his classical article on the health of individuals vs. the health of populations (18). Macrosocial analysis provides insight into major determinants of population health that go beyond individual risk factors. It answers questions such as “why is the homicide rate among young men much higher in Chicago than in Wales?” Most relevant to public health, macrosocial analyses lead to interventions that also occur at the macrosocial level – health and social policies – such as restricting access to firearms or eliminating racially segregated poverty.

Epidemiology cannot afford to ignore the health and social policy consequences of the macrosocial determinants of the health approach. What is more, the inadequacy of epidemiologic methods to deal with macro-determinants can be easily overcome. Cross-fertilization among methods is common in transdisciplinary domains such as genetic epidemiology. Social epidemiology has already shown openness to methods from other disciplines: multilevel modeling was developed in sociology of education; SEM with latent variables in political science. Important methodological issues in macrosociology (19) such as the use of case studies, the small n problem, or the analysis of time series will have to be addressed in social epidemiology. CAUSE FOR OPTIMISM?

Despite resistance to macrosocial determinants in epidemiology – the notion that only policies matter, not politics (an argument that would make democracy irrelevant as well) – signs for moderate optimism persist. Recently, global health, that analyzes macrosocial factors such as financial capital flows, wars, trade agreements, or welfare regimes and their impacts on population health, has blossomed (20). Nevertheless, global health is dominated by the new charity model of large foundations (Bill and Melinda Gates foundation) and donors (Warren Buffet, Bill Gates). Their emphasis is notably technological and biomedical. Owing to the huge influence that funding from the two richest persons can yield over this discipline, this giving could deter research on macrosocial determinants, in particular those that envision a central role for government redistribution.

There has been much interest in conditional programs for the poor, such as in the “Oportunidades” program in Mexico. Owing to the means-tested nature of these programs and the involvement of the private sector in the delivery of health services, it is important to compare them to government-financed and delivered universal programs such as Venezuela’s Barrio Adentro. Again, due in part to the support of global health donors (who, unlike the WHO, only represent themselves), the former type of program is capturing most attention in global health.

There is, however, a vibrant area of macrosocial research on the relation between politics, welfare state, and population health in comparative perspective (1, 21-25). Here the challenge is that many epidemiologists are more comfortable dealing with isolated policies than inquiring about the political and economic roots (social class alliances, political parties, unions, social movements) of sets of policies (the welfare state).

We conclude that Putnam and Galea have raised important issues that should be widely discussed among epidemiologists and public health scholars. Epidemiologists, health policy and public health scholars, health economists, and sociologists interested in macrodeterminants of health have reason to be optimistic about the chances to pursue these interests in the years to come. Resistance will continue within and outside epidemiology, but the reality of global integration, economic inequality, and an unstable political economy that does not meet the needs of the majority of the persons in the planet might be too overwhelming to ignore. Social epidemiologists should welcome transdisciplinary areas of inquiry and the growth of knowledge that emerges. Ultimately the fortunes of social epidemiology will also be influenced, not surprisingly, by macrosocial events outside the academic world.

REFERENCES

1. Navarro V, Muntaner C, Borrell C, Benach J, Quiroga A, RodriguezSanz M, et al. Politics and health outcomes. Lancet. 2.006; 368(9540):1033-7.

2. Muntaner C, Lynch JW. Income inequality, social cohesion, and class relations: a critique of Wilkinson’s neo-Durkheimian research program. Int J Health Serv. 1999;29(1):59-81.

3. Bunge M. Systemism: the alternative to individualism and holism. In: Boyd R, Florez-Malagon A, editors. Social Sciences and Transdisciplinarity. Montreal: CDAS; 1999.

4. http://www.who.int/social_determinants/, accessed 15 May 2008.

5. Benach J, Muntaner C. Aprender a Mirar la Salud. Barcelona: El Viejo Topo; 2005.

6. Lieberson S, Lynn FB. Barking up the wrong tree: scientific alternatives to the current model of sociological science. Ann Rev Social. 2002; 28:1-19.

7. Muntaner C, Oates GL, Lynch JW. Social class and social cohesion: a content validity analysis using a nonrecursive structural equation model. Ann N Y Acad Sci. 19995896:409-13.

8. Muntaner C, Chung H. Psychosocial epidemiology, social structure, and ideology. J Epidemiol Community Health. 2005;59(7):540-1.

9. Wagstaff A. Time series analysis of the relationship between unemployment and mortality: a survey of econometric critiques and replications of Brenner’s studies. Soc Sci Med. 1985;21(9):985-96.

10. Brenner MH. Unemployment, economic growth, and mortality. Lancet. 1979;1(8117):672.

11. Muntaner C, Lynch JW, Oates GL. The social class determinants of income inequality and social cohesion. Int J Health Serv. 1999;29(4): 699-732.

12. Muntaner C, Lynch JW, Davey Smith G. Social capital and the third way in public health. In: Labonte R, editor. Critical Perspectives in Public Health. Oxford: Oxford University Press; 2008.

13. Tesh S. Hidden Arguments. New Haven: Yale University Press; 1989.

14. O’Campo P, Gielen AC, Faden RR, Xue X, Kass N, Wang MC. Violence by male partners against women during the childbearing year: a contextual analysis. Am J Public Health. 1996;85(8, Part 1)11092-7.

15. Diez-Roux AV, Nieto FJ, Muntaner C, Tyroler HA, Comstock GW, Shahar E, et al. Neighborhood environments and coronary heart disease: a multilevel analysis. Am J Epidemiol. 1997;146(1):48-63.

16. Soderfeldt B, Soderfeldt M, Jones K, O’Campo P, Muntaner C, Ohlson CG, et al. Does organization matter? A multilevel analysis of the demand-control model applied to human services. Soc Sci Med. 1997;44(4)=527-34.

17. Muntaner C. Social epidemiology: no way back. A response to Zielhuis and Kiemeney. Int J Epidemiol. 2001;30:625-6.

18. Rose G. Sick individuals and sick populations. Int J Epidemiol. 2001;30(3):427-32.

19. Peters BG. Comparative Politics: Theory and Methods. New York, NY: New York University Press; 1998.

20. Chung H, Muntaner C. Welfare state typologies and global health: an emerging challenge. J Epidemiol Community Health. 2008;62:282-3.

21. Navarro V, Shi L. The political context of social inequalities and health. Int J Health Serv. 2001;31(1):1-21.

22. Navarro V, Borrell C, Benach J, Muntaner C, Quiroga A, Rodriquez-Sanz M, et al. The importance of the political and the social in explaining mortality differentials among the countries of the OCED, 1950-1998. Int J Health Serv. 2003;33(3):419-94.

23. Chung H, Muntaner C. Political and welfare state determinants of population health. Soc Sci Med. 2006;63(3):829-42.

24. Chung H, Muntaner C. Welfare state matters: a typological multilevel analysis of wealthy countries. Health Policy. 2007;80(2):328-39.

25. Espelt A, Borrell C, Rodriguez-Sanz M, Muntaner C, Pasarin MI, Benach J, et al. Inequalities in health by social class dimensions in European countries of different political traditions. Int J Epidemiol. 2008, (March 13 [Epub ahead of print]).

CARLES MUNTANER1 and HAEJOO CHUNG2

1 Departments of Psychiatry, Public Health Sciences, and Nursing,

University of Toronto, Toronto, ON, Canada

2 Department of Political Science, Faculty of Arts and Science, University of Toronto,

Toronto, ON, Canada

Correspondence: Carles Muntaner, Health Sciences Building, University of Toronto, 386-155,

College St, Toronto, ON, MsT iP8, Canada, E-mail: [email protected]

Journal of Public Health Policy (zoo8) 2.9, 199-306.

doi:io.io57/jphp.2.oo8.z3

ABOUT THE AUTHORS

Carles Muntaner is the Chair, Psychiatry and Addictions Nursing Research in the Social Policy and Prevention Research Department at the Centre for Addictions and Mental Health (CAMH). He is also a professor at the faculty of nursing with a cross-appointment in the Department of Public Health Sciences, Faculty of Medicine, University of Toronto.

Haejoo Chung is currently CIHR IHSPR post-doctoral fellow at the University of Toronto and research scientist for the employment relations HUB (EMCONET) of the WHO commission on Social Determinants of Health.

Copyright Palgrave Macmillan Limited 2008

(c) 2008 Journal of Public Health Policy. Provided by ProQuest LLC. All rights Reserved.

Population-Level Risk Factors, Population Health, and Health Policy

By Naumova, Elena N Cohen, Steven A

Putnam and Galea challenge the epidemiological framework underlying conventional public health research. They underscore the need to address population-level macrosocial determinants of health in epidemiological studies. Studying the population-level factors that ultimately determine population health is surely essential to policy development and implementation, as public health policy is disseminated at the population level. What impedes incorporation of macrosocial determinants of health into the epidemiological domain, leaving today’s playing field to individual-level socioeconomic conditions, or micro-social determinants – often outside the health policy domain? The idea that in addition to individual-level risk factors, macrosocial factors operating at the population level affect health is not new. In 1973, Mervyn Susser pointed out that “a determinant can be any factor…that brings about change for better or worse in a health condition” (i) and does not necessarily occur on the individual level. Because of resistance to incorporating population-level factors in epidemiological studies, the potential for social epidemiology to be a meaningful paradigm for researchers, policymakers, and practitioners of public health has yet to achieve its full potential.

One of the major strengths of Putnam and Galea’s article is the delineation of four major barriers to the large-scale incorporation of macrosocial determinants of health into the epidemiological literature: the appreciation of these determinants in epidemiological research; the potential for excess subjectivity in this approach; the traditional caution used in interpreting population-level to individual-level associations (the ecological fallacy); and the dearth of appropriate research and statistical methods to analyze populationlevel effects on population health appropriately. In each case, the authors astutely argue that these alleged barriers actually strengthen the logic for incorporating macrosocial determinants of health in public health research. Perhaps their most important point is that epidemiologists need to change their collective perspective on population-level determinants. Interactions between macrosocial determinants and health should not be obstacles to avoid in research, but rather challenges to meet. Moreover, these complex associations and interactions between population-level determinants and population health enrich the understanding of individual-level risk factor distribution in the population and their associations with health.

In addition to the barriers delineated by Putnam and Galea, we note numerous other practical explanations as to why macrosocial determinants of population health have yet to be fully explored in the epidemiological literature. Availability of data needed to undertake population-based studies stands out. Sometimes reliable population data on diseases and contextual factors of interest are not available. For outcomes or diseases, national and local surveillance data quality and coverage vary by disease and location (2). Accurate and timely population-based data may be limited for contextual sociodemographic factors, such as income.

In the United States, some of the data most widely used in research can be obtained from the US Census Bureau, but the national census is conducted only every 10 years. For the intercensal years, interim data exist for socioeconomic and demographic characteristics, but the data coverage on some measures is sporadic. With the development and implementation of the American Community Survey by the US Census Bureau, more reliable data for small areas and on a continuous timeframe should be more readily available in the near future (3). Both the demography and epidemiology communities would benefit from collection and dissemination of population data.

As Putnam and Galea explain, compared to more traditional individual-level risk factor-based epidemiology, few reliable, flexible, and applicable summary measures of population health and specific disease burden exist. Susser and Susser elaborated upon this view while suggesting that the lack of standardized and validated population-based methodologies may account for their underuse (4). But several statistical tools suitable for population- level analysis do exist.

Multi-level or hierarchical linear modeling, for example, is a class of techniques involving sophisticated modeling of population- and individual-level factors that has contributed greatly to the advancement of public health knowledge (5). Mixed effects models and generalized estimating equation (GEE) procedures constitute two powerful methods of multi-level modeling that can accommodate the longitudinal nature and correlated data structure inherent in population-level analyses. Despite their utility for capturing population-level influences on health outcomes, several inherent obstacles to their universal implementation persist: proper training in advanced statistics; model specification to suit the hypothesis being tested; and difficulty interpreting model parameters.

Conceptualization of these models is substantially more complex than traditional linear models, thus full understanding of the underlying concepts behind these methods requires advanced training, which is generally lacking in many public health masters and doctoral programs. Interpretation of these models is not always transparent and visualization of results is often less than straightforward. seemingly minor mistakes in specification of multi- level models can lead to erroneous conclusions about the role of macrosocial factors as they relate to population health. Multi- level modeling procedures are much more computationally demanding than standard linear regression models and require specialized software and are often prohibitively expensive and difficult to use. Complex modeling procedures such as GEE and mixed effects models are not included in all statistical software packages. Where statistical programs do contain these modeling procedures, running similar analyses using different statistical packages may yield different results.

More emphasis should be placed on developing sound methods and measures to study larger-scale, population-level determinants of health that can, either independently or together with other factors, modify health. With the goal of making these methods more easily understandable for use and interpretation by the public health community, biostatisticians, epidemiologists, and other public health professionals should work together to create guidelines for using these methods.

More practical challenges confront those implementing a population-level approach to health research. Two overarching conceptual obstacles must be overcome to realize fully the potential and need to incorporate these factors into the standard epidemiological research paradigm. The traditional belief that the best way to assess causality is with a randomized, controlled trial is first. Biostatisticians have devoted enormous resources to and developed comprehensive methods to analyze data from randomized controlled trials. In comparison, while statistical techniques to analyze population-level socioeconomic data with population-level health outcomes exist, they have not, as Putnam and Galea explain, been explored as deeply.

One of the most appropriate designs for a study of macrosocial determinants of population health is not the randomized, controlled trial, but rather the ecological study. The literature surrounding study design itself has long regarded the ecological study design to be one of the weakest for determining causation of individual risk factors to individual outcomes (6). Studies of population-level macrosocial determinants of population health do not purport to draw individual-level conclusions about risk factors and health outcomes. To assess how population-level factors influence health at the aggregate level, ecological study designs are the logical choice. Just as the ecological study is useful for evaluating population- level associations, analysis of spatial clustering and time-series modeling can be used to assess spatio-temporal associations between population-level risk factors and outcomes. Time-series analyses, although often regarded as weak study designs to assess causality, can indeed demonstrate one of the key criteria for causality mentioned by Bradford Hill: the exposure must precede the outcome (7). To assess temporal aspects of population-level macrosocial determinants of health almost demands active use of time-series analysis. Characteristics inherent in or affecting the entire population, such as herd immunity, income inequality, and their spatio-temporal variability, would have little meaning on the individual level. They can be best evaluated through the use of ecological, spatial, or time-series analyses (8).

The Gini Index, a measure of population-level inequality, is an example of a measure that can be defined only on the population level. This population-level characteristic has been a subject of increasing exploration and analysis in the medical and public health literature. The relationship between income inequality and health has been explored on several geographical levels and in various settings. Lynch et al. found that after controlling for the absolute income level, wealthy countries with higher income inequality tended to have higher infant and child mortality rates than similar countries with lower income inequality (9). Gravelle and Sutton found similar spatiotemporal associations in the United Kingdom between income inequality and infant mortality, as well as cause- specific mortality later in life (10). Herd immunity, defined as the indirect protection of populations from infection resulting from the presence of immune individuals (n), is another example of an epidemiological concept that cannot be defined on the individual level, and is reserved for populations. An influential analysis that assessed the long-term temporal trends in vaccination of school children and excess mortality comparing Japan and the United States ultimately led to the new CDC recommendations for universal influenza vaccination for children to achieve indirect protection of other subpopulations (12). For decades, demography and economics have embraced the major macro-level social determinants with respect to societal development, large-scale demographic and epidemiological transitions, and mortality. These fields have focused traditionally on the complex social interactions, environmental changes, and economic and technological advances that have either led to or hindered the development of societies. Their approaches can be adapted for epidemiology and public health research, including the development of new perspectives and blending of interdisciplinary perspectives that transition from the individual to the population level. Challenging customary epidemiological paradigms by incorporating demographic techniques and perspectives will surely inform public health research and policy, providing a more complete picture of the factors that contribute to population health. One such contribution would be to account for population-level spatio- temporal changes in disease patterns and transmission. Similarly, the concept of susceptibility to disease demands a life-span approach, not just a life-stage approach, incorporating the idea that social and economic development on the local, national, and even global levels can ultimately change disease patterns for populations (13).

A cohort approach is another example of extending demographic techniques to critical population health problems. An age- periodcohort approach was used to assess trends in breast cancer mortality rates over time in Spain (14), as well as for lung cancer mortality patterns across nations (15). The cohort perspective centers on the potential for health outcomes later in life to be affected by the common experience to a set of large-scale socioeconomic and environmental conditions at a common age contemporaneously throughout the life span. To further the understanding of populationlevel determinants of health, the public health research community should adopt and incorporate the principles and methodologies commonly used in demographic research.

The aforementioned transitions toward a more population-based, life span approach to health have the potential to affect public health policy downstream in major ways. Policy, whether health- related or not, is established at the national, state, and municipal levels rather than at the individual level. Policies that ultimately affect population health – vaccination recommendations or requirements, redistribution of wealth, environmental policies, behavioral modifications, and countless others – have far-reaching consequences and can affect health in ways previously unknown or unintended.

In an ideal world, rigorous scientific research informs policies adopted to maximize population health. However, there are several important considerations that often impede this process, ranging from logistics to economics, and the politics mentioned by Putnam and Galea. Consider the recent policy recommendation for universal influenza vaccination of children (i2.,i6). Clinical trials can readily determine the effectiveness and safety of such a policy for individual child. But vaccination of schoolchildren may have indirect benefits in the adult and elderly populations through herd immunity. To study this question demands a population-based approach that cannot be achieved through clinical trials. Population-based, macro-level analysis affords the researcher, and ultimately policymakers, the ability to assess in the population the indirect benefits of such a policy. Research can address macrosocial effects and their interactions with influenza rates in the population rates, measuring vaccine shortfalls, vaccine coverage trends, the associations with socioeconomic characteristics, and numerous other properties of the population.

Individual risk factor-based epidemiology is critical to understanding disease dynamics and prevention, remaining relevant to innumerable conditions affecting the population. Nonetheless, these individual risk factors are not distributed randomly in the population. Ultimately, population-level determinants of health are those driving forces that both serve to distribute those individual risk factors, and to mitigate population health through collective experience. Incorporation of population-level determinants involves both subtle and sweeping changes to the current public health research framework. Surely, these changes will not occur overnight.

We hope that, in time, public health researchers will more fully explore these important contextual variables to improve population health domestically and abroad; these researchers will better understand the importance of these factors in all aspects of risk factor epidemiology. The public ultimately contends with any health policy aimed at improving public health. To us, it surely makes sense to address potentially modifiable factors at the population level, factors that can be addressed to protect the health of the population.

REFERENCES

1. Susser M. Causal Thinking in the Health Sciences. New York, NY: Oxford University Press; 1973.

2. Weber SG, Pitrak D. Accuracy of a local surveillance system for early detection of emerging infectious disease. JAMA. 2.00352.90: 596-598.

3. US Bureau of the Census. American Community Survey (ACS)- About the Data (Methodology): Multiyear Estimates Study. Website: http:// www.census.gov/acs/www/ AdvMeth/Multi_Year_Estimates/ overview. html, accessed 2.9 January 2.008.

4. Susser M, Susser E. Choosing a future for epidemiology: II. From black boxes to Chinese boxes. Am J Public Health. 1996;86:674- 8.

5. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. 1st edition. Hoboken, NJ: Wiley; 2.004.

6. Tower RL, Spector LA. The epidemiology of childhood leukemia with a focus on birthweight and diet. CnY Rev CHn Lab Studies. 2007544:203-42.

7. Last JM, editor. A Dictionary of Epidemiology. 3rd edition. New York: Oxford University Press; 1995.

8. Zeger SL, Irizarry R, Peng RD. On time series analysis of public health and biomedical data. Ann Rev Pub Health. 2.00652.7:57- 79.

9. Lynch J, Smith GD, Hillemeier M, Shaw M, Raghunathan T, Kaplan G. Income inequality, the psychosocial environment, and health: comparisons of wealthy nations. Lancet. 20015358:194-200.

10. Gravelle H, Sutton M. Income related inequalities in self assessed health in Britain: 1979-1995. J Epidemiol Comm Health. 2003557:125-9.

11. Fine PEM. Herd immunity: history, theory, practice. Epidemiol Rev. 1993515:265-302.

12. Reichert TA, Sugaya N, Fedson DS, Glezan P, Simonsen L, Tashiro M. The Japanese experience with vaccination schoolchildren against influenza. N Engl J Med. 20015344:889-96.

13. McMichael AJ. Prisoners of the proximate: loosening the constraints on epidemiology in an age of change. Am J Epidemiol. 19995149: 887-97.

14. Cayuela A, Rodriguez-Dominguez S, Ruiz-Borrego M, GiIi M. Ageperiod-cohort analysis of breast cancer mortality rates in Andalucia (Spain). Ann Oncology. 2004515:686-8.

15. Liaw Y, Huang Y, lien G. Patterns of lung cancer mortality in 23 countries: application of the age-period-cohort model. BMC Public Health. 2.00555:2.2-9.

16. Centers for Disease Control and Prevention (CDC). ACIP Provisional Recommendations for the Prevention and Control of Influenza. 2.5 March, 2.008. Website: http://www.cdc.gov/vaccines/ recs/provisional/ downloads/flu-3-zi-o8-5o8.pdf.

ELENA N. NAUMOVA and STEVEN A. COHEN

Tufts University School of Medicine, Boston, MA, USA

Correspondence: Elena N. Naumova, Tufts University School of Medicine, 136 Harrison

Avenue, Boston, MA OZIII, USA. E-mail: [email protected]

Journal of Public Health Policy (2.008) 29, 290-298.

doi:10.1057/jphp.2008.21

ABOUT THE AUTHORS

Dr. Elena N. Naumova is a professor at the Tufts University School of Medicine and Director of InForMID, the Tufts University Initiative for the Forecasting and Modeling of Infectious Diseases. Her expertise is the development of analytical tools for time series and longitudinal data analysis applied to disease surveillance, exposure assessment, and studies of growth. Her research activities span a broad range of research programs in infectious disease, environmental epidemiology, molecular biology and immunogenetics, nutrition and growth.

Dr. Steven A. Cohen is an assistant professor at the Tufts University School of Medicine and a member of InForMID. His primary training is in population studies pertaining to public health policy and programs. He is interested in the modeling and prediction of infectious disease dynamics in the United States and assessing health care utilization practices in the US elderly population.

Copyright Palgrave Macmillan Limited 2008

(c) 2008 Journal of Public Health Policy. Provided by ProQuest LLC. All rights Reserved.

Molecular Imaging/Therapy: It’s Only Useful If It’s Useful-and Available

By DeNardo, Gerald

Advances in imaging technology have made it possible to view molecular pathways within living individuals as never before. However, molecular imaging and therapy have existed for more than a half-century and are based on long-established concepts and methods (see suggested references for support for statements made in this commentary). As molecular techniques come to the forefront in medicine, it has become clear that, just as a diversity of scientists is required to advance basic knowledge in the field, we will need physicians from multiple disciplines, crossdisciplinary training, and a commitment to cooperative exploration if the potential of molecular imaging therapy is to be fulfilled. In the middle of the last century, scientists capitalized on tracer methodologies using radionuclides to investigate disease. These scientists had a variety of academic backgrounds, and those with medical degrees were from a range of disciplines, including pathology, surgery, internal medicine, pediatrics, and radiology (which included radiotherapy). They shared a common passion to understand health and disease, an understanding of the new field of radionuciide technology, and the access and ability to work with tracer technologies. Recognizing that medical technology should influence patient care, they developed therapeutic and diagnostic methods, some of which continue to be useful today (although often improved by better technology).

To share information, small gatherings were organized. These meetings led to formalization of the Society of Nuclear Medicine (SNM), with its first meeting in 1953 and first journal in 1961. SNM and The Journal of Nuclear Medicine became international vehicles for communication of scientific developments in the field. Twenty years later, a remarkable group of individuals identified the need to formalize a medical discipline around clinical and research procedures based on the use of radionuclides for molecular applications. The proposal was met with enthusiasm by organized medicine. Formal support for a new specialty board in nuclear medicine initially came from the American Boards of Internal Medicine (ABIM), Radiology (ABR), and Pathology (ABP) and from SNM. Belated opposition from the American College of Radiology (ACR) and ABR led the American Board of Medical Specialties to approve a compromise: a conjoint board, the American Board of Nuclear Medicine (ABNM), cosponsored by ABIM, ABR, ABP, and SNM. Each of these cosponsoring organizations would appoint 3 individuals to the ABNM board of directors. The initial board, appointed in 1971, included Joseph Kriss, MD, Richard Peterson, MD, and Joseph Ross, MD, from ABIM; Frederick J. Bonte, MD, E. Richard King, MD, and David E. Kuhl, MD, from ABR; Tyra Hutchins, MD, Ralph Kniseley, MD, and W. Newlon Tauxe, MD, from ABP; and Merrill Bender, MD, Paul Harper, MD, and Henry N. Wagner, Jr., MD, from SNM. Nuclear medicine stands on the shoulders of these giants. Scientific pioneers in their own right, they established a board certifying individuals in all aspects of the medical use of radionuclides, including therapy and imaging.

Leaders have visions that extend beyond their own selfinterests. The early giants in nuclear medicine envisioned a 3-legged stool contributing to better care for patients. All legs of the stool were deemed important to the integrity of nuclear medicine and included molecular-targeted radionuclide therapy, molecular-targeted radionuclide therapy, molecular imaging, and molecular diagnostics. The seat supported by and uniting these legs was made up of research and development. All were believed to be important and integral to the well being of patients and medicine. With this strong foundation and a growing body of scientific knowledge and professional accomplishment, ABNM became an independent board in 1985.

Shifting Paradigm, Stable Foundation

Today an important paradigm shift to individualized or personalized medicine is occurring. Molecular imaging and therapy are in the forefront of this trend, especially for cancer. For the most part, current cancer therapies are population based; that is, targeted at an “average patient.” The goal now is to individualize treatments to improve response and safety. Drugs that work in one individual may be ineffective or cause adverse events in others. Imaging may distinguish responders from nonresponders and promote early changes in management for those who do not respond. The National Cancer Institute’s new guidelines for a complete response in lymphoma, now defined by an absence of uptake on imaging in a previously ^sup 18^F-FDG-avid malignancy, provide an example of the many potential roles of molecular imaging in cancer.

Webster’s dictionary defines medicine as “the science and art of diagnosing, treating, curing, and preventing disease.. .and improving and preserving health.” Dorland’s dictionary similarly defines medicine as “the art or science of healing diseases; especially the healing of diseases by the administration of internal remedies.” Note the emphasis on healing and treating. Molecular imaging and nuclear medicine are almost self-explanatory; the previous focuses on molecules and the latter on atomic nuclei. Groups within our profession have defined nuclear medicine as “the medical specialty that uses the tracer principle, most often with radiopharmaceuticals, to evaluate conditions of the body for the purposes of diagnosis, therapy and research” and molecular imaging as “the visualization, characterization, and measurement of biological processes at the molecular and cellular levels in humans and other living systems.”

Nuclear medicine is, however, increasingly characterized as merely 1 among many promising molecular imaging approaches. This is despite its position as the stable foundation upon which molecular imaging and therapy rest. Although broader in applications for research and development, molecular imaging is and has been essentially radionuclide-based at the clinical level. This is the origin and prototype of technology that has prevailed for more than a half-century. Although imaging combinations may yield additional information, translation for some imaging methods to clinical applications will be difficult. MR imaging provides intrinsic molecular information that can define metabolic pathways and the effect of therapy on these pathways, but it has not progressed in the clinic very far beyond characterization of vessels and vascular spaces. Optical imaging provides a powerful means for research visualization, because it is relatively inexpensive and readily available. But despite substantial enthusiasm from researchers and funding agencies, inherent limitations have prevented either of these imaging methods from translating broadly to the clinic. Both violate the principles of methodology required to accurately trace extrinsically introduced molecules. Tracer methodology requires that: (1) the molecule is not altered by the tracer and (2) the molecular process is not altered by the tracing molecule. Radionuclides are exceptionally well suited for these purposes. Nuclear imaging is highly sensitive, quantitative, and readily translated to human subjects. Radioisotope emissions are not as attenuated as fluorescent signals and, therefore, are less depth dependent. Simply stated, tracer methodologies using radionuclides and radionuclide signal detection are likely to continue to dominate molecular imaging at the clinical level because of their inherent advantages.

Successes and Questions

No other discipline of medicine has proven as continuously exciting over the years as nuclear medicine. As Henry N. Wagner, Jr., MD, has stated, “this is the best-kept secret in medicine.” There is long history of an intimate relationship between diagnosis and therapy facilitated by nuclear medicine techniques. Today, the promise of molecular imaging to play an important role in accounting for individual variations of disease and for personalizing the diagnostic strategy is unlikely to be fulfilled in the absence of therapeutic relationships. Although molecular therapy encompasses a much broader range of approaches, molecular-targeted radionuclide therapy provides the most intimate and interdependent relationship of molecular imaging with molecular therapy. The availability and direction of molecular imaging in the future seems likely to depend on current research and successes in molecular therapy.

We have seen some stunning successes. More-effective, less-toxic drugs for lymphoma based on molecular-targeted radionuclide imaging have been approved, with numerous reports of high response rates and favorable long-term outcomes-including reports of cures in otherwise untreatable disease. These drugs compare favorably by almost any standard with competing pharmaceutical regimens, and many believe that these new approaches should be administered earlier in the course of disease progression.

Yet these new molecular-targeted radionuclide-based regimens are markedly underused, even in markets where patients are actively asking for access. Whereas rituximab (Rituxan), a drug for immunotherapy of lymphoma, has been a market success, related drugs 90Y-ibritumomab (Zevalin) and I31l-tositumomab (Bexxar) are so underused that the New York Times and other major U.S. newspapers have published articles about the need to expand access. The situation is so counterintuitive to the notion of providing optimal diagnosis and treatment to patients who need it most that we must ask ourselves and our colleagues in other disciplines difficult questions: Why is this so? Is it because there is no longer an advocacy group for molecular-targeted radionuclide therapy? Should we be actively taking the facts to patients and their advocacy groups? More important and significant for long-range planning is the question of whether nuclear medicine has failed to provide and require adequate therapy training. Have radiation and medical oncology likewise failed to show an interest in molecular-targeted radionuclide-based therapies, so that individuals from these disciplines lack both basic knowledge and defined access? If nuclear medicine focuses solely on molecular imaging, then a vacuum exists and is likely to grow. There is a need for leadership, novel strategies, and partnering with other groups. Oncologists have been accused of “withholding” these treatments for economic and territorial reasons. This is as unacceptable as our failure to ensure that these therapies are readily available to needy patients. Responsible for patient welfare, we can no longer shy away from speaking out.

Going Forward

Nuclear medicine once attracted the best. The future of nuclear medicine and molecular imaging and therapy depends on the long-term availability of talented and passionate scientists and physicians- not on advances in technology. “It is not necessary to change. Survival is not mandatory,” wryly noted the efficiency and productivity expert W. Edwards Deming. If we are to survive, we must have foresight and wisdom. Transformations in patient care can be facilitated by molecular medicine, but only if physicians are trained to provide that care. Organizations already exist with the influence and infrastructure to move forward with training this workforce. In the United States, the SNM’s mission is “to improve health care by advancing molecular imaging and therapy.” ABNM aims to ensure that physicians meet adequate standards for delivering patient care using nuclear technologies for molecular tracing and therapy. These 2 groups will be looked to as leaders in identifying changes that can lead to the creation of the molecular imaging and therapy workforce of die future.

How will this workforce be different? Given the current challenge of available therapeutics with verified success but limited use, we must ask additional hard questions about the training that nuclear medicine physicians should receive. Do we currently have sufficient focus on the ethical and social responsibilities of each physician and scientist involved in patient care? A therapeutic option is inherent in the definition of medicine and should be seen as an integral pan of our field. If molecular tracing (imaging) leads, for example, to a decision that therapy should not be given, then this implies that a therapeutic option exists. We must think like a patient and distinguish that which a physician does from that which a “technocrat” does.

Physician diversity will be required if nuclear medicine is to participate in the full realization of the potential of molecular imaging and molecular-targeted radionuclide therapy. This is a problem that we can and must resolve now. We must identify where and how education in molecular-targeted radionuclide therapy is provided in training programs today, and this effort must not be restricted by traditional discipline boundaries. With additional training, many individuals specializing in medical oncology and radiation oncology- as well as nuclear medicine-have backgrounds that should enable them to engage in moleculartargeted radionuclide therapy. Either new organizations will develop or the existing organizations must embrace this diversity by showing the same willingness as our field’s founders to cross boundaries and plan together to adapt to the ever-changing promise of medical progress.

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Gerald DeNardo, MD

Professor Emeritus, Internal Medicine, Radiology,

and Pathology

University of California Davis Medical Center

Sacramento, CA

Copyright Society of Nuclear Medicine Sep 2008

(c) 2008 Journal of Nuclear Medicine, The. Provided by ProQuest LLC. All rights Reserved.

Myocardial Sympathetic Innervation in Patients With Symptomatic Coronary Artery Disease: Follow-Up After 1 Year With Neurostimulation

By Fricke, Eva Eckert, Siegfried; Dongas, Aristidis; Fricke, Harald; Preuss, Rainer; Lindner, Oliver; Horstkotte, Dieter; Burchert, Wolfgang

In both diabetic and nondiabetic patients, there is a loose correlation between coronary flow reserve (CFR) and sympathetic innervation in viable myocardial segments. The loose correlation implies that sympathetic innervation may be preserved even with major impairment of myocardial blood supply. In some patients, denervation is due to repetitive episodes of ischemia in areas with severely reduced CFR. We investigated the long-term effect of reduced CFR on myocardial sympathetic innervation in diabetic and nondiabetic patients with spinal cord stimulation. Methods: We analyzed 23 patients (10 diabetic and 13 nondiabetic) with coronary artery disease and without known cardiac autonomie neuropathy. At baseline, we determined quantitative myocardial blood flow using ^sup 13^N-ammonia PET, myocardial viability using ^sup 18^F-FDG PET, and cardiac innervation using ^sup 11^C-hydroxyephedrine (HED) PET. At the 1-y follow-up we measured CFR and ^sup 11^C-HED retention. During follow-up, no cardiac intervention was performed and no myocardial infarction occurred. In all patients, spinal cord stimulation was performed for relief of angina. Results: There was no significant difference in segmental ^sup 11^C-HED retention between baseline and follow-up in the whole patient group. In diabetic patients, as well as in segments with severely reduced CFR (

J Nucl Med 2008; 49:1458-1464

DOI: 10.2967/jnumed.108.052340

In both diabetic and nondiabetic patients, there is a loose correlation between coronary flow reserve (CFR) and sympathetic innervation in viable myocardial segments (1,2). The loose correlation implies that sympathetic innervation may be preserved even with major impairment of myocardial blood supply. In some patients, denervation is due to repetitive episodes of ischemia in areas with severely reduced CFR.

We investigated the long-term effect of reduced CFR on myocardial sympathetic innervation in diabetic and nondiabetic patients with spinal cord stimulation (SCS) for refractory angina pectoris. During the follow-up, all patients were stable on medication and none underwent a coronary intervention.

The effectiveness of SCS in relieving symptoms in patients with coronary artery disease (CAD) has been shown (3,4), Numerous studies have demonstrated the efficacy of SCS in improving exercise tolerance, decreasing the frequency of anginal episodes, and prolonging the time to electrocardiographic signs of ischemia (5). There is evidence that the pain modulation is due to an inhibition of nociceptive unmyelinated fiber afferents by non-nociceptive myelinated fiber afferents (“gate control theory”) (6,7). Redistribution of myocardial blood flow or even an increase in myocardial blood flow has been discussed as well (8,9). Because it is still an open question whether SCS influences myocardial blood flow, we measured CFR at the follow-up investigation as well.

MATERIALS AND METHODS

Patient Population

We analyzed 23 patients (2 women and 21 men; mean age +- SD, 64 +- 9 y) with chronic CAD. Ten of the patients had type 2 diabetes. In 3 patients, diabetic disease was newly diagnosed. In the remaining 7 patients, the duration of known diabetic disease was 12.1 +- 11.4 y. Glycosylated hemoglobin was 6.9% +- 0.9%, confirming good glycemie control in most patients. Baseline PET was performed to verify the indication for SCS in patients with angina pectoris refractory to medical treatment and without the option of coronary intervention. All patients had angina pectoris, CCS score III or IV (classification of the Canadian Cardiovascular Society) (10). Most patients had 3-vessel disease (22/23), 1 patient, single-vessel disease. Sixteen (70%) of 23 patients had a history of myocardial infarction. Left ventricular ejection fraction measured by echocardiography was 49.7% +- 6.3% in the nondiabetic patients and 43.4% +- 10.7% in the diabetic patients. Patient characteristics are summarized in Table 1.

Patient Investigations

At baseline, 4 PET investigations were performed on each patient. All scans were performed using an ECAT EXACT HR+ PET scanner (CTI/ Siemens Medical Systems). Quantitative myocardial blood flow was determined using ^sup 13^N-ammonia PET. For viability testing, ^sup 18^F-FDG PET was performed. ^sup 11^C-hydroxyephedrine (HED) PET was performed for cardiac innervation imaging.

Patients were allowed to continue their medication. Only beta- blocking agents were withdrawn, 24 h before ^sup 11^C-HED PET. The medication consisted of beta-adrenoblockers (n = 20), angiotensin- converting enzyme inhibitors (n = 19), long-acting nitrates (n = 20), diuretics (n = 15), statins (n = 21), and antiplatelet drugs (n = 20). All patients took short-acting nitrates if an anginal attack occurred. The patients were asked to abstain from caffeinecontaining food or medication 24 h before the stress investigation.

At the 1-y follow-up, ^sup 11^C-HED PET and quantitative measurement of myocardial perfusion were performed using the same investigation protocols and the same analyses. To improve the comparability between the PET studies with the different tracers on the one hand and between the baseline and the follow-up study on the other hand, the same software was used for the definition of the polar maps in all studies. There was no change in the medication of the patients during follow-up. No cardiac intervention was performed, and no myocardial infarction occurred.

PET

Quantification of Myocardial Blood Flow. Segmented attenuation correction was performed on the basis of a 5-min transmission scan (^sup 68^Ge/^sup 68^Ga rod source) before tracer application. PET scans were acquired dynamically (12 x 10 s, 5 x 30 s, 2 x 120 s, 1 x 450 s) after a bolus injection of 500-600 MBq of ^sup 13^N- ammonia under rest and stress conditions. At rest, heart rate and blood pressure were measured. Mean arterial blood pressure (systolic plus diastolic divided by 2) was documented, as well as the rate- pressure product (product of heart rate and systolic blood pressure divided by 100). Pharmacologic stress was performed with adenosine (Adenoscan; Sanofi-Aventis GmbH) (0.14 mg/kg/min) over 6 min. Blood pressure (mm Hg) was monitored during adenosine infusion at 1, 3, and 5 min after the beginning of the infusion. Transaxial images were reconstructed iteratively using 4 iterations with 8 subsets of the ordered-subset expectation maximization algorithm). Dynamic area- conserving polar maps were generated using the software created by van den Hoff et al. (11). Quantification of the ammonia studies was based on the irreversible 2-tissue-compartment model described by Hutchins et al. (12). An averaged metabolite correction of the input function was performed on the basis of the results of Rosenspire et al. (13). CFR was calculated by dividing segmental stress perfusion values by segmental rest perfusion values. Coronary resistance was calculated by dividing the mean arterial blood pressure, averaged from the 3 measurements during adenosine infusion, by the segmental stress perfusion value.

Viability Testing. All patients underwent euglycemic- hyperinsulinemic clamping in preparation for PET. An infusion of 2.3 IU of insulin and 2 mmol of potassium chloride solution in 100 mL of 10% glucose was given over 1 h. In patients with a blood glucose level greater than 160 mg/dL, additional insulin was given intravenously depending on the individual blood glucose level. Halfway through the clamping, 350-400 MBq of ^sup 18^F-FDG were injected. Acquisition began 30 min after injection. A transmission scan of 10 min was followed by a static emission scan of 15 min. Area-conserving polar maps of relative ^sup 18^F-FDG uptake were generated using the same software as for the perfusion studies.

Cardiac Sympathetic innervation. After a transmission scan of 10 min, 750-800 MBq of ^sup 11^C-HED were injected as a slow bolus over 30 s. Dynamic PET acquisition was initiated simultaneously (6 x 30 s, 2 x 60s, 2 x 150 s, 2 x 300 s, 2 x 600 s, 1 x 1,200 s). Image reconstruction was performed as described above. ^sup 11^C- HED retention (%/min) was calculated by dividing the mean segment activity (kBq/mL) of the last frame over the integrated arterial activity (kBq/ mL/min) derived from the ventricular blood pool (14,15). TABLE 1

Patient Characteristics

TABLE 2

Hemodynamic Parameters at Baseline and Follow-up

TABLE 3

Parameters for Viable Segments of All 23 Patients

Statistical Analysis

The left ventricular myocardium was divided into 20 segments (16). For all PET studies, polar maps were generated using the same software to prevent systematic errors caused by different algorithms.

^sup 18^F-FDG uptake values were normalized individually to the segment with the highest rest perfusion value. In all patients, rest perfusion in the reference segment was normal, so it can be assumed that viability in the reference segments was preserved. A cutoff of 0.7 for normalized ^sup 18^F-FOG uptake was chosen to define scarred segments. This cutoff was applied because beyond this value there is no more correlation between ^sup 11^C-HED retention and normalized ^sup 18^F-FDG uptake (1). Most analyses were performed for viable segments only. Just ^sup 11^C-HED retention was compared both in all segments and in viable segments only.

A paired t test was performed to compare ^sup 11^C-HED retention, PET perfusion values, CFR, and coronary resistance in the baseline and follow-up studies. Linear regression analysis was used to test for systematic deviations between baseline and follow-up. Furthermore, myocardial segments were subdivided into 4 groups based on CFR values. These groups consisted of segments with CFR that was normal (>/=3), mildly reduced (2 = x

FIGURE 1. Linear regression of segmental rest perfusion (A), stress perfusion (B), CFR (C), and coronary resistance (D) in nonscarred segments of all 23 patients at baseline (x-axis) and follow-up (y-axis).

RESULTS

Comparison of Baseline Study and Follow-up Study in Whole Collective

There was no significant change in mean arterial blood pressure at rest, rate-pressure product at rest, heart rate, or mean arterial blood pressure during adenosine infusion between baseline and follow- up (Table 2).

Values for ^sup 11^C-HED retention, flow values, and coronary resistance in the viable segments are given in Table 3. There was no statistically significant difference in any of the parameters given. Rest perfusion values showed the largest variation between baseline and follow-up (Fig. 1A). Among the different perfusion parameters, coronary resistance showed the highest consistency between the studies (Figs. 1B-1D).

^sup 11^C-HED retention agreed well between the baseline and follow-up studies. An example is given in Figure 2. The correlation coefficient was a little bit higher if all segments were included (Fig. 3A). For the nonscarred segments, the correlation coefficient for the ^sup 11^C-HED retention between the studies was 0.78.

Comparison of Baseline Study and Follow-up Study in Nondiabetic and Diabetic Patients

Values for ^sup 11^C-HED retention, flow values, and coronary resistance in the viable segments for the 2 subgroups are given in Table 4. There was a small but significant decrease in ^sup 11^C- HED retention in the viable segments of the diabetic subgroup. Still, the regression coefficient was a little higher in the diabetic subgroup than in the nondiabetic subgroup (Figs. 3C and 3D). In the nondiabetic patients, significant changes occurred neither in ^sup 11^C-HED retention nor in the flow parameters. In the diabetic patients, a significant increase in both stress flow and CFR occurred, whereas the increase in coronary resistance was not significant.

Comparison of ^sup 11^C-HED Retention in Viable Segments at Baseline and Follow-up Classified by CFR

Table 5 shows ^sup 11^C-HED retention in the viable segments at baseline and follow-up classified by CFR. In segments with severely reduced flow reserve (

DISCUSSION

To our knowledge, this is the first long-term study investigating sympathetic myocardial innervation in patients with stable CAD using ^sup 11^C-HED PET. The first interesting finding is that the measurement of ^sup 11^C-HED retention is highly reproducible. Despite the period of 1 y, the correlation coefficient between the studies is high. This high correlation is especially noticeable when one compares the results of the innervation studies with those of the perfusion studies, which show much lower correlation coefficients. The lowest correlation is shown between the rest studies. One possible explanation is that resting myocardial perfusion heterogeneity is a typical feature of CAD itself (17). The natural course of CAD might differ between the patients, too. Even differences in metabolic parameters, such as HDL cholesterol or insulin levels in the plasma, might increase the variability of flow parameters (18,19). The variability of blood flow at rest accounts for the variability of CFR as well. Coronary resistance, which is normalized to arterial blood flow, shows the smallest variability in blood perfusion values.

FIGURE 2. A 75-y-old patient with 3-vessel disease. Bypass graft surgery had been performed 9 y before baseline study; actual coronary angiography revealed dysfunction of graft supplying marginal branch. (A) ^sup 18^F-FDG PET at baseline showed no sign of myocardial infarction. (B) Stress perfusion at baseline revealed severe perfusion defect in mid anterior and lateral walls. (C) ^sup 11^C-HED PET at same time point showed diminished ^sup 11^C-HED retention in segments with diminished stress perfusion. (D and E) One year later, without interim cardiac intervention and after 1 y of SCS, there was little change in myocardial stress perfusion (D) and ^sup 11^C-HED retention (E).

FIGURE 3. Linear regression of segmental ^sup 11^C-HED retention at baseline (x-axis) and follow-up (y-axis) in all segments (A), nonscarred segments (B), nonscarred segments in nondiabetic patients (C), and nonscarred segments in diabetic patients (D).

The ^sup 11^C-HED retention values in our study are lower than those that other groups have measured in healthy volunteers (14,20,21). One reason for the difference is the methodology used. We calculated ^sup 11^C-HED retention by dividing the mean myocardial activity of the last frame (40-60 min) by the integrated arterial activity derived from the ventricular blood pool, and we did not correct for metabolites. As shown by Munch et al. (22), use of earlier frames, as well as correction for metabolites, leads to higher values for ^sup 11^C-HED retention. Another reason for the lower ^sup 11^C-HED retention is the severe and symptomatic CAD in all our patients.

TABLE 4

Time Course of ^sup 11^C-HED Retention and Perfusion in Viable Segments of 13 Nondiabetic and 10 Diabetic Patients

TABLE 5

^sup 11^C-HED Retention (%/min) in Myocardial Segments Categorized into Groups Based on CFR

Aside from the methodologic point of view, the result also shows that there is little change in myocardial sympathetic innervation over time in the absence of myocardial infarctions or coronary interventions. There are only a few exceptions, in which significant changes could be shown. The first exception is ^sup 11^C-HED retention in viable segments with severely reduced myocardial flow reserve. The small but significant decrease in ^sup 11^C-HED retention in these segments most probably reflects progressive ischemic neuronal damage (1,2). Still, the difference is apparent only in cases of severe reduction of CFR, not in cases of moderately reduced CFR (Table 4). In segments with only mildly reduced CFR (2

Another exception is diabetic patients. The mean segmentai ^sup 11^C-HED retention does decrease significantly (Table 3), although the correlation coefficient between the segmental ^sup 11^C-HED retention at baseline and follow-up is even a little higher than in nondiabetic patients (Fig. 3). One might argue that the reduction in ^sup 11^C-HED retention is due to progressive autonomie neuropathy (25), but other causes cannot be ruled out, for example, the lower blood flow under stress conditions in the diabetic subgroup (Table 3) or the diminished LV function (Table 1).

Our data have been collected from patients in whom SCS was initiated shortly after the baseline study due to anginal pain refractory to standard treatments. Although we can rule out the possibility that our results have been influenced by myocardial infarctions, coronary interventions, or changes in medication, we cannot rule out that the neurostimulation itself had an impact. The question is whether our results can be applied to other CAD patients, in whom SCS is not performed. The answer to this question is not obvious, mainly because the mechanisms behind the effects of SCS are not completely understood (7,25). The effect of SCS might be due to improvement in myocardial blood flow (8,9,27). Our data do not support this thesis, as blood flow under rest and stress conditions, as well as CFR, did not change significantly (Table 2). Another hypothesis is that SCS reduces sympathetic tone, decreasing myocardial oxygen consumption and improving myocardial microcirculatory blood flow (26,28). We cannot rule out the possibility that the assumed reduction in sympathetic tone leads to a protective effect on the sympathetic neurons themselves, causing the neurons to be less susceptible to ischemic damage. It is difficult to provide a control group of nontreated patients because patients with proven ischemia are usually treated by revascularization or, if coronary intervention is not an option, by alternative approaches. The prognostic relevance of sympathetic denervation in viable myocardium is still under discussion. There is evidence that the autonomic nervous system plays a major role in the pathogenesis of sudden cardiac death (29-31), Actually under investigation is whether ^sup 11^C-HED PET is suitable for risk assessment for sudden cardiac death (32). We have shown that sympathetic innervation does change slightly over time, despite symptomatic CAD and severely reduced CFR. Interestingly, percutaneous coronary intervention, when added to optimal medical therapy, did not reduce the risk of death or other major cardiovascular events (33). Both findings might be related in the following sense. The temporary improvement in myocardial blood supply caused by the percutaneous coronary intervention is unlikely to change the innervation pattern of the left ventricular myocardium. Because the innervation pattern itself is a major risk factor for sudden cardiac death, percutaneous coronary intervention might not reduce the risk of death either. The possible interrelationships between revascularization procedures, myocardial sympathetic innervation, and prognosis will be a matter of further investigations.

CONCLUSION

In the absence of cardiac intervention or myocardial infarction, there is little change in sympathetic innervation of the myocardium in either diabetic or nondiabetic patients in a 1-y follow-up. In myocardial segments with severely altered blood flow, a small but significant decrease in ^sup 11^C-HED retention most probably reflects ischemic neuronal damage. The prognostic relevance of sympathetic denervation in viable myocardium still has to be determined.

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Eva Fricke1, Siegfried Eckert2, Aristidis Dongas3, Harald Fricke1, Rainer Preuss1, Oliver Lindner1,

Dieter Horstkotte2, and Wolfgang Burchert1

1 Institute of Radiology, Nuclear Medicine and Molecular Imaging, Heart and Diabetes Centre North Rhine-Westphalia, Bad

Oeynhausen, Germany; 2 Department of Cardiology, Heart and Diabetes Centre North Rhine-Westphalia, Bad Oeynhausen,

Germany; and 3 Institut of Anesthesiology, Heart and Diabetes Centre North Rhine-Westphalia, Bad Oeynhausen, Germany

Received Mar. 3, 2008; revision accepted May 28, 2008.

For correspondence or reprints contact: Eva Fricke, Institut fur Radiologie, Nuklearmedizin und Molekulare Bildgebung, Herz- und Diabeteszentrum Nordrhein-Westfalen, Georgstrasse 11, 32545 Bad Oeynhausen, Germany.

E-mail: [email protected]

COPYRIGHT (c) 2008 by the Society of Nuclear Medicine, Inc.

Copyright Society of Nuclear Medicine Sep 2008

(c) 2008 Journal of Nuclear Medicine, The. Provided by ProQuest LLC. All rights Reserved.

Community Action Agency in Oklahoma City Offers Business Course

The Community Action Agency is offering a five-week small business training course from 6 p.m. to 8 p.m. Tuesdays and Thursdays from Sept. 30-Oct. 30.

The cost is $25. Topics will include legal issues, financials, tax issues, marketing, advertising, e-commerce, business plan development and funding.

Enrollment information is available by calling the Economic Development Division of Community Action Agency at (405) 232-0199.

Originally published by Journal Record Staff.

(c) 2008 Journal Record – Oklahoma City. Provided by ProQuest LLC. All rights Reserved.

3-Year-Old Colo. Boy Dies of E. Coli

Health officials in Colorado are investigating the death of a 3-year-old boy who contracted E. coli poisoning.

The source of the bacteria, as well as the strain of the virus that infected the Arapahoe County child, have not yet been determined, the Denver Post reported Tuesday.

The child attended a private in-home day-care center. A Tri-County Health Department official said it is possible for feces contaminated with E. coli to be spread in a day-care center where there’s diapering.

AARP Names Four California Employers As Best Employers for Workers Over 50

PASADENA, Calif., Sept. 23 /PRNewswire/ — Four employers from California have been named to the AARP list of 2008 Best Employers for Workers Over 50, announced today. Scripps Health of San Diego, Wells Fargo & Company of San Francisco, Northern California Presbyterian Homes & Services of San Francisco and The Aerospace Corporation of El Segundo join a diverse group of 50 forward-thinking employers, recognized by AARP for demonstrating that enlightened policies toward 50-plus employees make good business sense. The complete list can be found at http://www.aarp.org/\bestemployers.

“In California, corporations, educational institutions and health care employers are increasingly recognizing the importance of innovative policies — such as, flexible work schedules, retiree relations programs, professional development, good health benefits and opportunities to save for retirement — as they seek to retain and recruit experienced workers,” said AARP California State Director Tom Porter.

“These employers have demonstrated progressive policies and programs for workers over 50, and have earned the honor,” added Porter.

New to this year’s list are Bay-area companies Wells Fargo & Company and Northern California Presbyterian Homes & Services. Both companies, along with Scripps Health and The Aerospace Corporation, offer a variety of creative programs for experienced workers, including phased retirement, return-to-work programs and retiree websites designed for former employees.

Other employers which were acknowledged by AARP for their outstanding programs include Cornell University, which finished first; Scripps Health of San Diego, which finished second, and S. C. Johnson and Son, Inc. of Racine, Wisconsin, third. S. C. Johnson was first in 2007. The National Institutes of Health (NIH) became the first federal agency to receive the AARP honor since the program began in 2001. NIH finished eleventh.

The Best Employers winners, and the winners of a separate International Innovative Award, will be honored at a dinner on October 7 in Chicago. A CEO roundtable will also be held that day, focusing on AARP’s new Workforce Assessment tool and the critical need to manage talent and anticipate future employee needs.

AARP The Magazine will feature the 2008 Best Employers in its November-December issue, in homes September 25, along with an extensive feature story on recareering and discovering new passions at age 50+. The complete article and list can also be found online at http://www.aarpthemagazine.org/.

AARP invites employers to apply for the Best Employers honor by submitting an electronic application outlining their exemplary policies and practices toward 50 and over workers.

Candidates are vetted to ensure that practices meet the needs of mature workers. Key areas of consideration include: recruiting practices, opportunities for training, education and career development; workplace accommodations; alternative work options, such as flexible scheduling, job sharing, and phased retirement; employee health and pension benefits; retiree work opportunities, and training and development.

   2008 Best Employers Winners   Rank, Company Name                                 City, State    1   Cornell University                             Ithaca, NY   2   Scripps Health                                 San Diego, CA   3   S. C. Johnson & Son, Inc.                      Racine, WI   4   The YMCA of Greater Rochester                  Rochester, NY   5   Lee Memorial Health System                     Fort Myers, FL   6   Securian                                       St. Paul, MN   7   First Horizon National Corporation             Memphis, TN   8   Stanley Consultants                            Muscatine, IA   9   Bon Secours Richmond Health System             Richmond, VA   10  Blue Cross Blue Shield Association             Chicago, IL   11  National Institutes of Health                  Bethesda, MD   12  Central Florida Health Alliance                Leesburg, FL   13  Brevard Public Schools                         Viera, FL   14  Massachusetts Institute of Technology          Cambridge, MA   15  Atlantic Health                                Morristown, NJ   16  TriHealth, Inc.                                Cincinnati, OH   17  Mercy Health System                            Janesville, WI   18  Adecco Group North America                     Melville, NY   19  Beaumont Hospitals                             Royal Oak, MI   20  L.L.Bean, Inc.                                 Freeport, ME   21  Massachusetts General Hospital                 Boston, MA   22  Jennings Center for Older Adults               Garfield Heights, OH   23  Blue Cross and Blue Shield of North Carolina   Durham, NC   24  Virginia Commonwealth University               Richmond, VA   25  Pinnacol Assurance                             Denver, CO   26  Saint Vincent Health System                    Erie, PA   27  National Rural Electric Cooperative       Association                                    Arlington, VA   28  Centegra Health System                         Crystal Lake, IL   29  Frankford Candy & Chocolate Co.                Philadelphia, PA   30  Nashoba Valley Medical Center                  Ayer, MA   31  George Mason University                        Fairfax, VA   32  Wells Fargo & Company                          San Francisco, CA   33  Horizon Blue Cross Blue Shield of New Jersey   Newark, NJ   34  Harvard University                             Cambridge, MA   35  Northern California Presbyterian       Homes & Services                               San Francisco, CA   36  Manheim                                        Atlanta, GA   37  ACUITY                                         Sheboygan, WI   38  DentaQuest                                     Charlestown, MA   39  The Aerospace Corporation                      El Segundo, CA   40  Express Personnel Services                     Oklahoma City, OK   41  Nevada Federal Credit Union                    Las Vegas, NV   42  Pepco Holdings Inc.                            Washington, DC   43  Michelin North America                         Greenville, SC   44  Intuitive Research and Technology Corporation  Huntsville, AL   45  Pearson                                        Upper Saddle River, NJ   46  CTTRANSIT                                      Hartford, CT   47  Vanguard                                       Valley Forge, PA   48  Centers for New Horizons                       Chicago, IL   49  Hanson Professional Services Inc.              Springfield, IL   50  FINRA                                          Washington, DC     About AARP  

AARP is a nonprofit, nonpartisan membership organization that helps people 50+ have independence, choice and control in ways that are beneficial and affordable to them and society as a whole. AARP does not endorse candidates for public office or make contributions to either political campaigns or candidates. We produce AARP The Magazine, the definitive voice for 50+ Americans and the world’s largest-circulation magazine with over 33 million readers; AARP Bulletin, the go-to news source for AARP’s 39 million members and Americans 50+; AARP Segunda Juventud, the only bilingual U.S. publication dedicated exclusively to the 50+ Hispanic community; and our website, AARP.org. AARP Foundation is an affiliated charity that provides security, protection, and empowerment to older persons in need with support from thousands of volunteers, donors, and sponsors. We have staffed offices in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.

AARP

CONTACT: Charee Gillins of AARP, +1-626-585-2606, [email protected]

Web site: http://www.aarp.org/http://www.aarpthemagazine.org/

Navarro Discount Pharmacies Launches Savings Club With $3-a-Month Meds and Free Delivery Service

Navarro Discount Pharmacies has launched a new customer service program aimed at helping patients save both money and time when filling their prescription medications. Navarro Discount Pharmacies is an MBF Healthcare Partners portfolio company.

The program, Navarro’s Savings Club, is a prescription discount club designed to offer patients with little or no insurance discounts on over 400 prescription medications. A one-time, lifetime membership fee of $9.99 covers the entire family including all children and pets.

For just $9.99 members may fill a prescription for 100 pills from more than 400 generic medications. That computes to $3 a month for medications taken one time a day, and $6 a month for those taken twice daily. Each tablet costs ten cents.

Free, next-day prescription delivery service is available and members also receive a $10 gift card with enrollment, as well as 10% off on more than 1,500 Premier Value brand products featured at Navarro.

Customers can sign-up on-line at www.navarro.com or, in person, at any neighborhood Navarro Discount Pharmacy. Membership is immediate.

“A really exciting and unique benefit for members is our free delivery service for prescriptions,” explained Albert Garcia, RPh, Executive VP Pharmacy Operations for Navarro. “This is a personal delivery service, not through the mail, and will arrive the day following the order at the customer’s choice of home or office.”

In the initial day of the new program, Navarro far exceeded their enrollment expectations by several hundred new members chain-wide throughout Dade and Broward counties.

Roger Lopez, RPh, Pharmacy Manager for a Navarro store on 8th Street in Miami, reported an overwhelming customer response and that many patients are coming from competing pharmacies.

“People are very excited about both the prescription program and the 10 percent discount on so many of our value items,” Lopez said. “It’s a really, really great program for the seniors who have run out of benefits at this point in the year, as well as those working for small businesses that do not offer any health coverage.”

For more information, stop by a neighborhood Navarro drugstore or visit www.navarro.com.

About Navarro Discount Pharmacies:

Navarro Discount Pharmacies is the largest Hispanic-owned drugstore chain in the United States. The company is known for its outstanding customer service and its unique offering of products and services dedicated to the healthy Hispanic household. Navarro has been serving the healthcare needs of the Hispanic community for over 60 years. The company leads the industry in average sales per store, sales per square foot and average prescriptions filled per store. www.navarro.com

About MBF Healthcare Partners:

MBF Healthcare Partners, LP is a private equity fund focused exclusively on investing in healthcare services companies and currently has $410 million under management. MBF is minority owned and operated. To learn more about MBF visit www.mbfhp.com.

Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference

CAMBRIDGE, Mass. and NEW YORK, Sept. 23 /PRNewswire-FirstCall/ — Ironwood Pharmaceuticals (formerly Microbia) and Forest Laboratories, Inc. today announced they will present results of a Phase 2b study investigating linaclotide’s safety and efficacy in 419 patients with irritable bowel syndrome with constipation (IBS-C) in a plenary session at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando, Fla. on October 7, 2008. Analysis of these data indicated that the study met its primary endpoint. Linaclotide is a first-in-class investigational compound being evaluated for its potential to treat IBS-C, chronic constipation (CC), and other gastrointestinal disorders.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

Ironwood and Forest also announced that they have initiated a comprehensive Phase 3 clinical program to evaluate linaclotide’s safety and efficacy in patients with either IBS-C or CC. The program will include two pivotal trials in IBS-C patients and two pivotal trials in CC patients, enrolling over 2,500 patients at approximately 250 clinical centers. The companies recently began patient dosing in the first CC trial and expect to initiate the second CC trial by the end of September, 2008. The companies expect to initiate both IBS-C trials by January, 2009.

IBS-C Phase 2b Study

This U.S. and Canada based, twelve-week, randomized, double-blind, placebo-controlled Phase 2b study was designed to assess the safety, efficacy, and dose-response of linaclotide in patients with IBS-C. Patients were randomized to receive placebo or linaclotide once-daily in the morning at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg. The companies released an interim analysis of the study results in March. The completed results to be presented at the ACG conference affirm this earlier analysis. In this study, the change from baseline vs. placebo for complete spontaneous bowel movement (CSBM) frequency-the study’s primary endpoint-was significant at all linaclotide dose levels. Notably, abdominal pain was clinically and statistically significantly reduced in all linaclotide treatment groups compared to placebo. Linaclotide-treated patients also experienced improvements in all other top-line efficacy endpoints-spontaneous bowel movement (SBM) frequency, stool consistency, bloating, abdominal discomfort, adequate relief, and IBS-C symptom severity-and these improvements were statistically significant for at least three of the four linaclotide dose groups for each endpoint. Linaclotide was well tolerated at all doses. The most common adverse event was diarrhea; however, there were no associated dehydration or electrolyte abnormalities, and discontinuations due to diarrhea were infrequent.

About Linaclotide

Linaclotide is a first-in-class compound currently being evaluated for the treatment of IBS-C, CC, and other gastrointestinal disorders. In Phase 2b studies in patients with IBS-C, linaclotide reduced abdominal pain and relieved constipation-the hallmarks of the condition-throughout the 12-week treatment period. Patients with CC who received linaclotide in Phase 2b studies experienced a significant improvement in bowel function as well. Linaclotide was well tolerated at all doses, with the most common adverse event being diarrhea. Positive results from a linaclotide Phase 2b study in 310 patients with CC were detailed in May 2008 at the Digestive Disease Week conference in San Diego. Linaclotide was designed to exert its effect on the intestine with minimal systemic exposure. Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine. In preclinical testing, linaclotide was shown to decrease visceral pain, increase fluid secretion into the intestine, and accelerate intestinal transit. A United States patent covering linaclotide composition of matter expires in 2025. In September 2007, Ironwood and Forest Laboratories entered into a 50/50 collaboration to co-develop and co-promote linaclotide in the United States. Ironwood retains exclusive rights to linaclotide outside of North America.

About Irritable Bowel Syndrome (IBS)

One out of six adults in developed countries suffers from IBS, a chronic condition marked by abdominal pain and disturbed bowel function. IBS accounts for 12% of adult visits to primary care physicians and is the most common disorder diagnosed by gastroenterologists. Healthcare costs associated with IBS exceed $25 billion annually. IBS patients fall largely into three subgroups-constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and mixed IBS (IBS-M)-and 30% to 40% of these patients suffer from IBS-C. There are currently few available therapies to treat the nine million U.S. patients diagnosed with IBS-C.

About Chronic Constipation (CC)

As many as 26 million Americans suffer from CC. Patients with CC often experience hard and lumpy stools, straining during defecation, a sensation of incomplete evacuation, and fewer than three bowel movements per week. The discomfort of CC significantly affects patients’ quality of life by impairing their ability to work and participate in typical daily activities.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (formerly Microbia) (http://www.ironwoodpharma.com/) is an entrepreneurial pharmaceutical company dedicated to the science and art of great drugmaking. The Company is advancing several clinical candidates-linaclotide for the treatment of irritable bowel syndrome with constipation, chronic constipation, and other functional gastrointestinal disorders; and novel, next-generation cholesterol absorption inhibitors for the treatment of hypercholesterolemia. Ironwood also has a growing pipeline of additional drug candidates in earlier stages of development. Microbia Precision Engineering, Inc., a majority-owned subsidiary of Ironwood, is an industrial biotechnology company developing and commercializing novel bioprocesses for the production of specialty chemicals. Ironwood has raised $231 million in private equity financing and is located in Cambridge, Massachusetts.

About Forest Laboratories Inc. and Its Products

Forest Laboratories is a US-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.frx.com/.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, [email protected]

Ironwood Pharmaceuticals; Forest Laboratories, Inc.

CONTACT: Susan Brady, Corporate Communications, IronwoodPharmaceuticals, +1-617-621-8304, [email protected], or Frank Murdolo,Vice President – Investor Relations, Forest Laboratories Inc.,+1-212-224-6714, [email protected]

Web site: http://www.frx.com/http://www.ironwoodpharma.com/

Outpatient Care Center Construction Raises Cost Concerns

By Kevin Lamb Staff Writer

SPRINGBORO — Compared to the 232,000-squarefoot structure its Cincinnati counterpart opened on I-75 last month, the Dayton Children’s Outpatient Care Center — Springboro won’t seem much bigger than a waiting room when it opens 21 miles up the road in November.

It has less than one-tenth the space of Cincinnati Children’s Hospital Medical Center’s new Liberty Twp. facility. Even counting the new physicians building at Atrium Medical Center in Franklin, Dayton Children’s will add less than one-fifth of Cincinnati’s new space.

But then it’s not really trying to answer Cincinnati Children’s.

“We build for what we think our needs are,” said Matt Graybill, Children’s Medical Center’s vice president for business development and planning. “The last thing we want to do is build a huge and expensive building, raise everybody’s health care costs and have it not be .”

As hospitals seem to be building at the rate of 1960s school construction, the impact on health care costs is a big worry for businesses already staggering under the weight of insurance premiums. A region’s per-capita health spending tends to rise with the supply of doctors and hospitals — not with the demands of people’s health status, considerable research shows. But health quality doesn’t rise with them.

Children’s hospitals are different, though. They have far fewer patients receiving expensive end-of-life treatment, no customers among the large and lucrative Baby Boom demographic and less competition from other hospitals. In Southwest Ohio, the pediatric hospitals’ relationship is “collaborative as well as competitive,” said Dee Ellington, Graybill’s Cincinnati counterpart, and even includes the sharing of patients.

“This Springboro facility is really an example of Dayton Children’s bringing their services out to where the community is,” said Rich Gunza, the Cincinnati resident who directs the Dayton office of Anthem Blue Cross and Blue Shield. He drives through the weedlike growth of Butler and Warren counties every day.

Since the Springboro center meets a clear patient demand, Gunza said, “I’m not worried from a cost standpoint that having more services available will bring about higher

utilization than the community needs.

“But what does concern me

is that when you move from

an old, paid-for facility to a

new one with all the technology, that cost all gets built

back into the hospitals’ pricing structure. I think any time

there’s new construction, a

community needs to ask the

question, ‘OK, it’s great to

have this new facility, but is it

really worth the extra cost?’

That question doesn’t get

asked often enough.”

Upgrading technology is one reason for the Springboro satellite, Graybill said. The Kettering Urgent Care center will become the Kettering Testing Center, with just imaging and lab testing when Dayton Children’s moves its urgent care and rehab operations to Springboro.

Equipment for breathing problems will be built into the Springboro walls instead of on portable carts. Doctors will be able to stitch up urgent-care wounds without “hauling a big light into the room,” Graybill said. Physical therapists will have the small gym that “you really need for pediatric rehab.”

Dayton Children’s can spend considerably less to modernize, however, than Cincinnati. “We have the second-largest pediatric research enterprise in the country,” Ellington said, trailing only Children’s Hospital Boston. Research brings myriad specialties and highend treatments, so Cincinnati Children’s Liberty Campus has 29 specialty clinics and surgery for 11 specialties.

All those specialists give Cincinnati a competitive advantage, but Ellington said, “Dayton Children’s supplies the services needed by the vast majority of people.” A choice between the two hospitals, he and Graybill agreed, also can come down to the doctor’s preference, which facility has the shortest wait for an appointment and of course, geography. Middletown and Lebanon form a nominal dividing line between the hospitals.

“Dayton Children’s has always had a real good outreach program in Middletown,” Gunza said. “You don’t hear a lot about it because they just go about filling community needs without a lot of fanfare.

“But when they build the Austin Road interchange, these guys will look like geniuses.”

Contact this reporter at (937) 225-2129 or klamb@DaytonDailyNews .com.

(c) 2008 Dayton Daily News. Provided by ProQuest LLC. All rights Reserved.

Three Big Causes for Cough That Won’t Go Away

DEAR DR. DONOHUE: Three months ago, I had a cold and cough. The cold has gone, but the cough hasn’t. I have used every commercial cough medicine, to no avail. The cough drives me and my wife crazy. It keeps her awake at night. I don’t feel all that bad, but I can’t stop coughing. What can I do? – R.S.

ANSWER: A cough lasting more than eight weeks qualifies as a chronic cough. Its three big causes are asthma, postnasal drip and gastroesophageal reflux (the upward spurting of stomach acid into the esophagus and sometimes the throat).

Asthma is detected through lung function tests. It’s a sudden narrowing of airways along with airway irritation, which fills the airways with thick mucus. Cough can be the only sign of asthma. If your cough is asthma-induced, asthma medicines should rid you of it.

Postnasal drip is the aggravating trickling of mucus from the nose and sinuses into the throat, where it triggers a cough reflex. Atrovent nasal spray and an antihistamine taken before bedtime often can stop the irritating drip.

Gastroesophageal reflux is heartburn. It can occur without heartburn pain. Stomach acid in the throat and airways sparks a bout of coughing that can almost always be controlled by medicines that turn down acid production. Prilosec is one example.

A cough that stays and stays after a respiratory infection like a cold can be handled in the same way as postnasal drip.

A long list of other cough causes exists, and you won’t be able to track the right one down without the help of your family doctor. Medicines like ACE inhibitors for blood pressure control make some people cough. Whooping cough is another cause of a chronic cough, and it’s often forgotten because people consider it a childhood illness. The cause that poses the greatest threat is lung cancer, and that’s something that needs to be addressed quickly.

DEAR DR. DONOHUE: For all my life, my nipples have hardly been visible. I am told this is called inverted nipples. Is this a sign of anything bad? I am only 23. Can they be fixed? – S.M.

ANSWER: Most inverted nipples only appear to be inverted. They have sunk somewhat into a depression in the breasts soft tissues. Squeezing them at their sides temporarily brings them out of the depression.

Nipples that can’t be everted by applying pressure to their sides are truly inverted nipples. Fibrous tissue arising from breast tissue has lassoed them and drawn them inward and into the breast.

In either case, surgery can correct the situation if a person desires it. Neither is a sign of a health problem.

Nipples that had been in the correct position and become inverted can be a sign of cancer and demand an investigation.

DEAR DR. DONOHUE: I have read on more than one occasion an item you have written on sciatica. Let me tell you a remedy that worked for me. I had pain that traveled down my left leg, and my doctor was working me up for sciatica. On one visit, he saw that I carried a thick wallet in my hip pocket. He told me to put it in a side pocket, and I did so. The pain left and has never returned.

ANSWER: Sitting on a thick wallet can cause sciatica pain. I should have mentioned it before. Moving the wallet to a side pocket takes care of the problem.

DEAR DR. DONOHUE: In a recent column, a correspondent asked if the kidneys are the seat of emotions. You answered from the standpoint of medical science that this is not the case. In the Hebrew Scriptures, the kidneys have a metaphorical sense as the seat of emotions. That makes as much sense as our practice of connecting love with the heart. – G.M.

ANSWER: Thanks, pastor. I wondered why the writer came up with that idea.

DEAR DR. DONOHUE: In the past 15 years, I have been admitted to the emergency room at least 10 times with atrial fibrillation. Every time it happens, I am tested, and my potassium is always very low. The first time it was 1.7.

They always give me potassium. At these times I have another strange symptom. I urinate gallons. When I do, I know my heart is going to start beating funny. I am tired of going to the ER so often. All the doctor does for me is give me a pill for my heart rhythm. I think the potassium loss is causing this. What do you think? – D.Q.

ANSWER: I think you’re right. The normal potassium level lies between 3.5 and 5.0 mEq/L. Your value of 1.7 is extraordinarily low. Heartbeat abnormalities can result at such a level, including the heartbeat abnormality of atrial fibrillation.

If no effort is being made to discover why your potassium drops as it does, take yourself to another doctor, preferably an endocrinologist or a nephrologist (a kidney doctor). Something is decidedly not kosher.

The booklet on sodium and potassium explains the role of these minerals and their importance to health. Readers can order a copy by writing: Dr. Donohue – No. 202, Box 536475, Orlando, FL 32853-6475. Enclose a check or money order (no cash) for $4.75 U.S./$6 Can. with the recipient’s printed name and address. Please allow four weeks for delivery.

Dr. Donohue regrets that he is unable to answer individual letters, but he will incorporate them in his column whenever possible.

(c) 2008 Sun-Journal Lewiston, Me.. Provided by ProQuest LLC. All rights Reserved.

Nipple Shield Protects Breast-Fed Child From HIV

Chemical engineer Stephen Gerrard of Cambridge University has developed a nipple shield that disinfects milk from a HIV-positive breast-feeding mother.

The shield uses a layer of cotton-wool soaked in a detergent used by biochemists to denature proteins for analysis. The chemical deactivates the virus, which prevents HIV transmission from a breast-feeding mother to her child.

The International Design Development Summit (IDDS) in the United States brought together engineers and field workers to work on research projects aimed at developing prototype designs.

Gerrard worked alongside a team of five engineers to create a practical design for heating breast milk to deactivate the virus, but soon realized that another method could be even more practical.

“We quickly established this may be too lengthy a process for many women in developing countries so they might not have the time for it,” he said.

“Research has shown that copper and copper compounds can work but another approach, carried out by a group at Drexel University seemed more promising.

“Their research has focused on sodium dodecyl sulphate (SDS), which can kill the HIV virus quickly and in fairly non-toxic concentrations.”

“We were concerned that using our nipple shield could be stigmatizing, since it would identify a mother as HIV infected,” said Mr Gerrard.

“We’re considering marketing it as a way to deliver medicines or micronutrient supplements to aid breast feeding. For example, they can also be used for iron or iodine deficiency.”

On the Net:

Dr. Edmund Kwan Offers Non-Surgical Nose Job for Ethnic Patients

NEW YORK, Sept. 23 /PRNewswire/ — Dr. Edmund Kwan, a New York-based surgeon specializing in plastic and cosmetic surgery for the ethnic patient, is now offering a non-surgical nose job as a new alternative to rhinoplasty surgery. The surgery is non-invasive and offers faster results and healing time. Completed in less than 20 minutes, the procedure requires no recovery time and is, on average, an eighth of the cost of traditional nose surgery. Results can last up to two years.

“The non-surgical nose job is an exciting alternative to surgery and is a great option for any individual seeking rhinoplasty, especially ethnic patients,” said Dr. Kwan. “Because this procedure is most often recommended to patients who would benefit from nasal implants, which are typically Asian, African-American and Hispanic individuals, ethnic patients are the ideal candidates for this procedure.”

Using an injectable gel called Juvederm, Dr. Kwan shapes or contours the nose to achieve the patient’s desired results. By making injections into precise areas of the nose the procedure can disguise a nasal bump or indentation, straighten or lift the nasal tip and increase the appearance of a flattened nasal bridge. Juvederm is also the first FDA approved hyaluronic acid filler that is proven to be safe and effective for persons of color.

“I always wanted a nose job but was nervous about the surgery and the possibility of not being satisfied with the final result,” said Dr. Kwan’s patient Eunmi Cho. “With the non-surgical nose job there was no commitment. If for any reason I wasn’t happy with the procedure I could easily go back to my natural look. With a few injections to the bridge of my nose Dr. Kwan made a subtle change that resulted in a great improvement to my profile.”

About Dr. Edmund Kwan

Dr. Kwan began his medical career by attending Georgetown University Medical School and performed his plastic surgeon residency at New York Medical Hospital-Cornell Medical Center and Sloan Kettering Cancer Center. He also trained with the world-renowned Dr. Robert Flowers, a pioneer in Asian plastic surgery, in Honolulu, Hawaii. Dr. Kwan is board certified by the American Board of Plastic Surgery (ABPS) and is a member of the American Society of Plastic Surgeons (ASPS). For more information, visit http://www.dredmundkwan.com/.

Dr. Edmund Kwan

CONTACT: Julie Sellew, Niwa Public Relations for Dr. Edmund Kwan,+1-646-644-5799, [email protected]

Web site: http://www.dredmundkwan.com/

New USP 797 Regulations May Create New Hazards for Compounding Pharmacy Directors

AGAWAM, Mass., Sept. 23 /PRNewswire/ — Though the new USP 797 regulations, which become effective June 1st, ease testing requirements, the impact of following the new minimums has the potential of creating new hazards for compounding pharmacy directors, warns Steven Wieczorek, Supervisor, Environmental Sciences, Microtest, Inc.

Issued by the U.S. Pharmacopoeia, the new version of USP 797 establishes bi-annual environmental sampling and testing as a minimum requirement, in place of the former monthly frequency. The regulations continue to require that pharmacies preparing compounded sterile preparations must have an effective plan and program that incorporate best practices and provide a clean, sterile working environment free of contamination.

Potential Hazards from Hidden Impacts

But Wieczorek says that adopting a bi-annual environmental testing program may impact a facility’s capability to maintain compliance. “Compounding pharmacy directors need to recognize the series of potential hazards lurking for them within the ‘hidden impacts’ of the new regulations.” Those hazards, he said, include:

— Bi-annual testing will not capture seasonal blooms of yeast, fungi, and bacteria.

— Problem tracking, diagnosis, and resolution will be difficult if environmental testing is conducted at six month intervals.

— The development of trend data that shows important seasonal fluctuations will be impossible when conducting bi-annual environmental testing.

— If a failure occurs during a bi-annual testing program, investigating up to 6 months of compounding activities and justifying what may or may not have been affected will be nearly impossible and extremely time consuming.

— With a monthly testing program, a failure will require investigation of only 3 to 4 weeks of data and will be significantly easier — saving large amounts of time and money. It will also help insure that the compounds prepared in your facility are sterile and will provide a safer final product for patients.

— Testing at a higher frequency will provide peace of mind. You will know that your controlled compounding environment(s), policies, and technicians are under control and in compliance. This will help reduce infections and save lives.

Wieczorek and Microtest (Agawam, Mass., http://www.microtestlabs.com/usp797) will continue to recommend a monthly testing regimen for all pharmacies compounding sterile preparations.

“A monthly testing regimen will continue to provide critical environmental and trend data of a pharmacy as the seasons change. Monthly testing will better reflect continued control of the compounding environment. It also will enable rapid problem resolution at a time when facilities are most vulnerable to non-compliance issues,” Wieczorek said.

“Under the regulations, the pharmacy director holds quality control responsibility and is accountable for the facility’s compliance performance. We believe that embracing best practices to create a plan that meets the pharmacy’s specific environment will achieve the greatest success,” he said.

Pharmacies failing to comply with USP 797 risk exposure to patient lawsuits as well as the potential loss of The Joint Commission’s (JCAHO) accreditation.

Free Facility-Gap-Analysis Audit

To help pharmacy directors set a benchmark, Microtest offers a free facility-gap-analysis audit to help compounding pharmacies determine their USP 797 compliance level and corresponding preparation. The audit includes an examination of the compounding pharmacy service’s physical facility footprint, drug compounding procedures, operational policies and training programs. Microtest experts will determine the level of compliance achieved, existing level of risk exposure, and recommendations to achieve compliance to USP 797.

“The audit will recommend the designated sterile compounding risk level of the pharmacy service as well as establish an accurate baseline for compliance program next-action development,” Wieczorek said “With the audit in-hand, pharmacy directors can then create a service plan.”

Microtest offers compounding pharmacy directors a single, one-stop resource of complete USP 797 compliance solutions — as advice, assistance, or complete implementation — available in an incremental approach or as a comprehensive, turnkey solution. Services include: program implementation, onsite training, custom SOP documentation, clean room design, environmental monitoring, and CSP product testing. To learn more, on the Web, visit http://www.microtestlabs.com/usp797 or call toll-free 1-800-631-1680.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Steve Richter, Ph.D. https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622

Microtest Labs

CONTACT: Don Goncalves, +1-781-793-9380, [email protected]; orCortney Lusignan, +1-781-793-9380, [email protected], both for MicrotestLabs

Web site: http://www.microtestlabs.com/http://www.microtestlabs.com/usp797

Arisyn Therapeutics Inc. Acquires Highly Novel Portfolio of Therapeutic Small Molecules for Infectious Disease and Cancer

FREDERICK, Md., Sept. 23 /PRNewswire/ — Arisyn Therapeutics Inc. (Arisyn) announced today day that it has successfully acquired from UAF Technologies and Research, L.L.C. (UTR) a series of highly novel small molecule inhibitors with a well-defined preclinical efficacy spectrum against a variety of infectious organisms and cancer. Under the terms of the assignment, Arisyn will assume the intellectual property portfolio. In return, UTR will receive a cash assignment fee, cash payments on the achievement of certain defined milestones and royalties on future sales of derivative drugs.

The assets involved in the transaction include molecules originally developed by The Proctor and Gamble Company, which were donated in 2003 to UTR for research at the University of Arizona. The therapeutic agents which constitute the portfolio target the replication of the human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis C virus (HCV), influenza virus, herpes viruses, and also include broad based inhibitors of cancer. Lead compounds from the series for HIV and cancer have already been tested in Phase 1 human clinical trials, while a lead inhibitor of HCV has progressed to the submission of an IND application with the FDA. The compounds inhibit virus replication by a highly unique mechanism of action involving inhibition of viral RNA transcription and have been found to be safe in extensive toxicological evaluations.

“These novel inhibitors form the basis of a new strategy to treat infectious disease by targeting a critical viral replication pathway within the infected cell and turning off the production of progeny infectious virus. The therapeutic agents should be highly effective additions to the combination therapy regimens currently used to treat infectious disease and of immense benefit to the millions of individuals chronically infected with organisms such as HIV and HCV,” noted Robert W. Buckheit, Jr., Ph.D., Director of Research and Development for Arisyn. “The compounds have proven efficacy and safety in preclinical studies and have shown significant promise to progress to Phase 1 human clinical trials for the treatment of HIV and cancer.”

The continued preclinical and clinical development of the compound portfolio will be performed by ImQuest BioSciences, a Contract Research Organization located in Frederick, MD specializing in the development of drugs for the treatment of infectious disease and cancer. ImQuest will perform necessary preclinical and clinical studies and manage the evaluation of Arisyn’s compounds in human clinical trials, as well as assist Arisyn with the discovery of next generation inhibitors of the novel therapeutic targets.

Bo Statham, UTR Manager, said he is very pleased that this promising technology has been assigned to Arisyn, a company that will focus exclusively on the development of these drugs.

About UTR

UTR is a limited liability company that was established to benefit the University of Arizona in the development of patents and other technology and to license or otherwise transfer such intellectual property to third parties.

About Arisyn Therapeutics Inc.

Arisyn Therapeutics Inc. is a privately held biotechnology company focused on the clinical development of small molecule therapeutics for infectious diseases and cancer. Arisyn’s strategy is to develop novel inhibitors with unique mechanisms of action for chronic diseases without effective therapeutic options such as HIV, hepatitis, and cancer. Arisyn Therapeutics Inc. is based in Frederick, Maryland and is on the web at http://www.arisyn.com/.

About ImQuest BioSciences, Inc.

ImQuest BioSciences, a privately held U.S. company located in Frederick, Maryland is a leading provider of anti-infective therapeutic and microbicide development and anti-cancer services to the biotechnology and pharmaceutical industry. ImQuest has broad based capabilities to assist companies with the discovery and preclinical development of new therapeutics, vaccines and preventatives, as well as the management of IND-directed programs for the evaluation of active products in human clinical trials. ImQuest is on the web at http://www.imquest.com/.

   For further information regarding this press release, please contact:    Robert W. Buckheit, Jr., Ph.D.   Director of Research and Development   Arisyn Therapeutics Inc.   (301) 644-3921   [email protected]    Bo Statham   [email protected]   (520) 519-9300  

Arisyn Therapeutics Inc.

CONTACT: Robert W. Buckheit, Jr., Ph.D., Director of Research andDevelopment of Arisyn Therapeutics Inc., +1-301-644-3921,[email protected]; or Bo Statham of UTR, +1-520-519-9300,[email protected]

Web site: http://www.arisyn.com/http://www.imquest.com/

Landauer Introduces Comprehensive Solution for Patient Radiation Monitoring

Landauer, Inc. (NYSE:LDR), a recognized leader in personal and environmental radiation monitoring, today announced the launch of their comprehensive patient monitoring solution, the microStar(R) system, now with nanoDot(TM) technology. This offering extends the applications for their proven Optically Stimulated Luminescence Dosimetry (OSLD) technology to address the growing demand for verification of patient radiation dose.

The patient-centric microStar solution facilitates even the most difficult measurements in therapeutic radiology, and has been clinically proven as a superior alternative to TLDs and diodes, especially for in vivo dosimetry applications where precise measurement of skin entrance dose is crucial. Some clinicians are hailing microStar as “the future of patient monitoring.”

The “microStar solution offers clinicians and their patients the reassurance of a second opinion on radiation dose,” explains Cliff Yahnke, Ph.D., Landauer’s Director of Technology and one of more than 12 physicists on staff worldwide. “It provides verification that patients are receiving the prescribed therapy.”

A single, simple, cost-effective solution for a variety of therapeutic environments, the microStar solution enables clinicians to work more efficiently because nanoDots have no dependence on irradiation angle or energy. No annealing or other labor-intensive preparation is required, and the portable microStar reader’s speedy throughput produces immediate results onsite, on demand.

Additionally, the non-destructive readout of nanoDot OSL dosimeters allows reanalysis, a feature not found in TLD and other dosimetry alternatives. This enables clinicians to record cumulative dose with multiple readings, and archive dosimeters for future reanalysis or to create a permanent dose record.

With healthcare’s recent focus on cumulative radiation dose from diagnostic procedures, the microStar solution may also be used to reassure patients that tests have been dose-optimized for greatest precision.

“OSL has proven its superiority to alternative technologies in occupational dosimetry. With its high degree of precision, ease of use and affordability, we believe it is the ideal complement for therapeutic radiology applications as well,” concludes Yahnke.

About Landauer

Landauer is the leading provider of analytical services to determine occupational and environmental radiation exposure. For more than 50 years, the Company has provided complete radiation dosimetry services to hospitals, medical and dental offices, universities, national laboratories, and other industries in which radiation poses a potential threat to employees. Landauer’s services include the manufacture of various types of radiation detection monitors, the distribution and collection of the monitors to and from clients, and the analysis and reporting of exposure findings.

Veterinary Surgical Associates and Veterinary Medical Specialists Install 1,000th Eklin Digital Radiography System

SANTA CLARA, Calif., Sept. 23 /PRNewswire/ — Digital radiography (DR) has been growing rapidly in veterinary medicine, accounting for a significant percentage of DR systems installed throughout the world. Eklin Medical Systems, a leader in veterinary DR, ultrasound, PACS (Picture Archiving and Communication Systems) and practice management software (VIA) announced the company has recently installed its 1,000th RapidStart DR system at Veterinary Surgical Associates (VSA) and its associate practices Veterinary Medical Specialists (VMS) and Tri-Valley Animal Emergency Center. VSA and VMS, leading Northern California providers of veterinary care, installed a third and fourth RapidStart system at the practices’ new facility in Dublin, California and will soon add two more systems for a total of six DR systems in VSA’s and VMS’ four Bay Area shared locations.

“Our mission is to improve the quality of veterinary medicine in the San Francisco Bay Area through the integration of science, compassion, and integrity, while giving the highest consideration to our patients, their human companions and the referring veterinarian that entrusts us with the care of them both,” said Chuck Walls, DVM, Diplomate ACVS, VSA. “To this end, we purchased Eklin’s DR solution because it provides better image quality than film-based x-rays in a fraction of the time. This gives us greater diagnostic confidence while often allowing us to begin treatment sooner, which many times can result in a far more positive outcome for the patient.”

Just as digital cameras have made photography easier and more efficient by eliminating film, DR systems provide the veterinarian with a radiographic image that can be viewed immediately onsite or at a review workstation, including a high-resolution monitor, without the need for film development. DR systems also offer sophisticated image processing tools, giving the doctor much greater depth of information that can be enlarged or manipulated for far better detail, resulting in closer scrutiny of potential areas of concern. Eklin offers either a 9″x11″ imaging sensor panel for large animal extremities, or a 14″x17″ sensor panel which provides the largest full imaging surface in the market and is equally suitable for large dogs or small cats.

The digital images are stored, archived and retrieved electronically through Eklin’s eFilm image management system. Based on DICOM standards, images from all compliant digital imaging modalities, such as ultrasound, MRI or CT, can be integrated for a comprehensive view of a patient’s imaging record. Images can be electronically shared throughout VSA’s and VMS’ multiple locations.

“It is important to have quick and easy access to our patients’ radiographs and other digital images,” said Julie Smith, DVM, VMS. “With the Eklin system, we can retrieve and review these images which can then be enhanced electronically to better focus on regions of interest or be shared with other experts throughout our collective practices. This ability can frequently improve our ability to make a diagnosis, giving us a valuable tool in optimizing our patient care.”

VSA offers a wealth of experience and expertise in all types of soft tissue, orthopedic and neurologic surgery. VMS provides the latest advances in internal medicine and oncology, often dealing with the most difficult and critical care-requiring patients. By teaming with VSA in the shared facilities, VSM patients receive the most comprehensive medical and surgical care available. VSA’s and VMS’ four Bay Area facilities are located in Campbell, San Mateo, Concord and Dublin.

“VSA’s and VMS’ commitment to outstanding patient care makes these highly skilled groups of professionals excellent representatives of our rapidly growing installed base,” said Gary R. Cantu, CEO and chairman, Eklin. “We developed the Eklin Digital Practice(R) to provide excellent image quality and workflow efficiencies in support of this commitment to superior patient care by all of our clients. We now look forward to the installation of our next 1,000 units.”

In addition to the historic 1,000th RapidStart system, VSA and VMS also installed Eklin’s 999th system in the new Dublin facility which opened its doors in August 2008. Along with digital radiography, the new 16,000 square foot facility provides ultrasound and helical CT scans. Veterinary specialty services include surgery, cardiology, oncology and internal medicine. VSA’s newest associated practice, Tri-Valley Animal Emergency Center, will provide emergency after-hour care within the same facility. An open house for area pet owners will be held at the Dublin practice on August 27, 2008 from 10 a.m. until 3 p.m.

About Veterinary Surgical Associates and Veterinary Medical Specialists

Veterinary Surgical Associates’ (VSA) team of surgeons provides exceptional coverage around the clock for both scheduled and emergency surgery. Veterinary Medical Specialists (VMS) provides the latest advances in internal medicine and oncology. Each VSA and VMS facility is staffed for 24- hour skilled compassionate nursing care – a prerequisite to attaining the desired outcome for many surgical and critical patients. Patients may be seen at any VSA and VMS hospital located in Campbell, San Mateo, Concord and Dublin, California. For additional information, visit http://www.vsasurgery.com/ or http://www.vmsmedicine.com/.

About Eklin Medical Systems, Inc.

With thousands of systems installed in private practices and universities around the globe, Eklin Medical Systems, Inc. is one of the world’s leading providers of veterinary PACS, practice management software (VIA), ultrasound and digital radiography products. Clients include more than 90 percent of U.S. veterinary schools of medicine, such as UC Davis, University of Ohio, Pennsylvania State and Texas A&M. Numerous zoos and marine facilities, including San Diego, Los Angeles, Bronx, SeaWorld and the U.S. Navy Marine Mammal Training Center, also employ Eklin Technology. Eklin is a privately- held company with reported sales revenues in excess of $35 million in 2007 and is headquartered in Santa Clara, Calif. The company can be contacted at 800- 819-5538 or visit http://www.eklin.com/.

    Media Contacts:     Jill Sweeten    VSA and VMS     (925) 288-4824    [email protected]     Laurie Hallwyler    Eklin Medical Systems    650-248-9081    [email protected]  

Eklin Medical Systems, Inc.

CONTACT: Media, Jill Sweeten of VSA and VMS, +1-925-288-4824,[email protected]; or Laurie Hallwyler of Eklin Medical Systems,+1-650-248-9081, [email protected]

Web site: http://www.eklin.com/http://www.vsasurgery.com/http://www.vmsmedicine.com/

Pilot Study of Wellstar’s Thermal Imaging Device Completed By Duke University Medical Center

Wellstar International, Inc. (OTCBB: WLSI), a developer of thermal imaging, diagnostic software and equipment, announced today that an important, pilot evaluation of the Company’s TMI infrared thermal imaging device has been completed by Duke University Medical Center. The device was utilized by physicians in the Wound Management Institute at Duke as a surveillance and assessment tool for the prevention of pressure ulcers and deep tissue injury. More information on the results of this study will be made available as soon as Wellstar receives the complete report.

ABOUT DUKE UNIVERSITY MEDICAL CENTER:

Duke University Medical Center, the hub of the Duke University Health System, is consistently ranked among the top ten health care organizations, and among the top five academic health centers, in the United States. The youngest of the nation’s leading medical centers, Duke has earned an international reputation for innovation and excellence. Duke operates one of the country’s largest clinical and biomedical research enterprises, and quickly translates advances in technology and medical knowledge into improved patient care. From new cardiac surgery techniques to stem cell transplants to wound care management, Duke scientists and physicians have pioneered many diagnostic and therapeutic “firsts,” many of which are now standard medical practice around the nation.

ABOUT WELLSTAR INTERNATIONAL, INC:

Wellstar International, Inc., through its wholly owned operating subsidiary Trillenium Medical Imaging, Inc. (TMI), is poised to become a leading diagnostic company in the health care industry. TMI has developed and is marketing fully calibrated and functional, thermal imaging systems that utilize state-of-the-art infrared technologies and proprietary software to accurately and cost-effectively measure physiological changes in the human body. More information on the Company and its unique diagnostic software and product line is available on Wellstar’s corporate Website, by visiting: www.wellstar.us.

FORWARD-LOOKING STATEMENTS:

This press release contains statements, which may constitute ‘forward-looking statements’ within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Important factors currently known to management that could cause actual results to differ materially from those in forward-statements include fluctuation of operating results, the ability to compete successfully and the ability to complete before-mentioned transactions. The company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.

 CONTACT:  Equiti-trend Advisors LLC (800) 953-3350 Toll-Free, U.S. & Canada (858) 436-3350 Local or International 9:30 a.m. to 5:00 p.m. Daily  

SOURCE: Wellstar International, Inc.

Largest SAVI Study Calls Experience ‘Outstanding’

Clinical experience with the SAVI(TM) breast brachytherapy applicator has been outstanding, according to a scientific poster presented at the 2008 Breast Cancer Symposium, Sept. 5-7, 2008 in Washington, D.C. The retrospective study evaluated the first 102 patients to undergo therapy with the device, making it the largest clinical review of the SAVI applicator to date.

Researchers concluded that SAVI expands the number of women with early-stage breast cancer who are eligible for breast brachytherapy. More than half of the evaluated patients were not candidates for balloon brachytherapy, due to skin spacing or breast size. Median follow-up time in the study was a full 10 months. The study was co-authored by physicians from the Department of Radiation Oncology, University of California San Diego, and Arizona Oncology Services (AOS) and the Breast Care Center of the Southwest, both in Phoenix, Ariz.

“The flexibility of SAVI expands the number of women for whom accelerated partial breast irradiation is a viable treatment option,” said Victor Zannis, M.D., a surgeon at the Breast Care Center of the Southwest and a co-author of the study. “The device is notable for its ability to conform to specific patient anatomy, as well as its ability to be used in small breasts and in proximity of normal body structures such as the skin or chest wall.”

SAVI is a single-entry, interstitial-style device that delivers radiation as part of breast conservation therapy. By more precisely targeting radiation therapy, the device treats the tissue where the cancer is most likely to recur, while minimizing the exposure of healthy tissue such as the skin, heart, lungs and ribs.

“Cianna Medical is proud to play a leading role in advancing breast cancer treatment, by providing more women with the option of customized care,” said Jill Anderson, the company’s President and CEO. “Thanks to the sophistication of this technology, the SAVI applicator makes a simple five-day course of radiation available to twice as many women than are currently eligible for balloon brachytherapy.”

According to researchers, what differentiates SAVI from other applicators is that it combines the ease of placement of single-entry brachytherapy devices with the improved dose modulation of interstitial brachytherapy.

“SAVI’s real advance is the nature of its open architecture design with multiple catheters. This makes it possible to contour the dose and gives physicians the ability to cover the target area while minimizing radiation exposure of non-targeted tissue,” said Catheryn Yashar, M.D., assistant professor and chief of breast and gynecological services in the UC San Diego Department of Radiation Oncology and a lead author of the study.

Unlike balloon brachytherapy applicators, which require skin margins of several millimeters, SAVI has no such skin spacing limitations. In the study, 23 patients had a skin spacing of less than or equal to 7 mm, and 34 patients had a chest wall spacing of less than or equal to 7 mm, yet the dose to normal structures remained “exceedingly low.”

Patient tolerance of the procedure was excellent. Of the 102 patients evaluated, only 8% had a palpable seroma, all of which were asymptomatic. In contrast, seroma rates with balloon brachytherapy are reported to vary from 15%-60%. The infection rate with SAVI in the study was 3%, which is comparable to the average rate of infections for breast procedures and substantially less than published infection rates for balloon brachytherapy.

About Cianna Medical, Inc.

Cianna Medical, Inc. is a medical device company focused on women’s health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The SAVI applicator allows contouring of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women. For more information about the company, call (toll-free) 866-920-9444 or visit www.SAVI.us.

Glogster Launches Education Development Program

Glogster, the new Web 2.0 platform that provides consumers with a revolutionary way of expressing their mood, feelings and ideas, today announced the launch of its education program, which aims to provide educators across the globe with access to digital learning tools for the classroom. The multi-phased program launches today with a partnership with teachers where Glogster will provide support for educators to begin integrating Glogster.com into the classroom and teachers will provide valuable feedback on what additional tools are needed to fully optimize the power of Web 2.0 in the classroom.

The education program has been created in response to Glogster’s growing popularity amongst both educators and teens around the world. To date, the site’s growing mass appeal, coupled with its free, user-friendly web building tools have made Glogster.com a helpful tool for teachers working to create a dynamic, interactive classroom experience. However, educators are clamoring for more education specific capabilities on the site. The program will address these needs through a collaboration between worldwide educators and Glogster to develop a ideal platform for the classroom setting.

In phase one of the program, Glogster will work with educators to build accounts for students that have permanent privacy settings so that all Glogs created in the classroom will remain private. Glogster will also help teachers with instructing students to import completed Glogs into classroom wikis so that the Glogs can be viewed and shared with classmates without providing access to outside web content. Additionally, Glogster will provide technical support as well as ideas and success stories on different ways teachers can best leverage the technology in the classroom.

“The variety and accessibility of web tools is both exciting and scary to today’s teachers, said Mary Rizzo, Technology Facilitator and Webmaster at Parsley Elementary School. “As educators, we want to expose our students to and integrate the use of the tools of today and of the future, all the while maintaining a safe learning environment.”

Rizzo goes on to say, “Glogster.com has created a unique web tool that would allow students the ability to easily create a webpage-like ‘poster’ that can integrate the arts with core curriculum content. Glogster understands my concerns about students only having access to a safe web environment and being able to only view other Glogster.com projects created by students in my school. I applaud them for taking the suggestions of educators and pursuing options that will make this wonderful tool a valuable part of the 21st Century classroom.”

Phase 2 of this program will roll-out in the upcoming months and will leverage the key data gathered in the first phase. The second phase will consist of a separate education platform that will provide educators with additional controls and privacy settings. The entire education program will continue to be an evolving, dynamic partnership between Glogster.com and educators to provide enhanced opportunities for today’s classrooms.

For more information on Glogster/edu, visit www.glogster.com/edu.

About Glogster

Glogster is the leading platform that gives consumers a revolutionary way of expressing their mood, feelings and ideas. Glogster allows members to create and share Glogs by using text, images, voice, video, special effects, links, sounds, designs and more. For more information on Glogster visit www.glogster.com.

Glogster is yours!

Clinical Study Results: Nutrition 21’s Iceland Health(R) Chromax(R) Chromium Picolinate Reduces Hunger, Food Intake and Cravings

PURCHASE, N.Y., Sept. 23 /PRNewswire-FirstCall/ — Nutrition 21, Inc. , the developer and marketer of nutritional supplements under the Iceland Health(R) and Diabetes Essentials(R) brands, reported today that results of a randomized, double-blind, placebo-controlled clinical study published online in Diabetes Technology & Therapeutics showed that Nutrition 21’s Chromax(R) chromium picolinate significantly reduced hunger levels by 24%, food intake by 25%, and also reduced cravings for high-fat foods in adult non-diabetic overweight women. The study was conducted by researchers at the Pennington Biomedical Research Center, the largest academically based nutrition research center in the world.

“Study subjects were allowed to eat any type and amount of food throughout the study. The participants who received chromium picolinate reduced their caloric intake by an average of 365 calories per day between their baseline and final (week 8) visit,” stated Dr. Steve Anton, investigator and lead author of the publication. “Not only are these results clinically significant, it is also noteworthy that participants receiving chromium picolinate did not report increased hunger levels despite significantly reducing their food intake.”

James Komorowski, M.S., vice president — technical services and scientific affairs for Nutrition 21, stated, “These results show that Chromax chromium picolinate can be useful for overweight individuals desiring to reduce their food intake. The published study also provides clinical substantiation for reduced hunger and reduced cravings claims for food and supplement manufacturing companies that use Chromax in their formulations.”

The randomized, double-blind, placebo-controlled, 8-week study, entitled “Effects of Chromium Picolinate on Food Intake and Satiety,” was published online in Diabetes Technology & Therapeutics (http://www.liebertonline.com/dia), and is scheduled to be released in the October 2008 print issue of the journal. The study population comprised 42 overweight adult women who reported craving carbohydrates. Subjects were administered either Chromax chromium picolinate capsules (containing 1,000 mcg chromium) or matching placebo capsules for 8 weeks. Food intake was directly measured at the research center’s eating laboratory at baseline, after 1 week and again after 8 weeks.

Michael A. Zeher, president and chief executive officer of Nutrition 21, commented, “The results of this study provide substantial evidence of the efficacy of Chromax in decreasing hunger and high-fat cravings. We are pleased that a renowned research center the caliber of the Pennington Biomedical Research Center, has completed independent research that validates the potential benefits of using Chromax on food intake and satiety levels. This new use can easily be incorporated within the framework of a sensible weight loss program. With a patent covering the use of chromium for reducing food cravings and appetite, Nutrition 21 is, again, in the right place, at the right time with safe and effective science-based products for our customers and consumers seeking solutions to their health care needs.”

About Pennington Biomedical Research Center

The Pennington Biomedical Research Center mission is to promote healthier lives through research and education in nutrition and preventive medicine. The Center is a campus of the Louisiana State University System and conducts basic, clinical and population research. The research enterprise at the Center includes 80 faculty and more than 40 post-doctoral fellows who comprise a network of 50 laboratories supported by lab technicians, nurses, dieticians, and support personnel, and 19 highly specialized core service facilities. The Center’s nearly 600 employees occupy several buildings on the 234-acre campus.

About Nutrition 21

Nutrition 21, Inc. , headquartered in Purchase, NY, is a nutritional bioscience company and the maker of chromium picolinate-based and omega-3 fish oil-based supplements with health benefits substantiated by clinical research. Nutrition 21 holds more than 30 patents for nutrition products and uses. Nutrition 21’s portfolio of health and wellness products include: Iceland Health Chromax(R), Iceland Health Life Advanced Memory Formula(TM), Diabetes Essentials(R), Iceland Health(R) Maximum Strength Omega-3 and Iceland Health(R) Joint Relief. The company also manufactures private label supplements and ingredients for third parties. Nutrition 21 distributes its products nationally through more than 29,000 major food, drug and super center stores throughout the United States and internationally. For more information please visit http://www.nutrition21.com/.

Safe Harbor Provision

This press release may contain certain forward-looking statements. The words “believe,””expect,””anticipate” and other similar expressions generally identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based largely on the Company’s current expectations and are subject to a number of risks and uncertainties, including without limitation: the effect of the expiration of patents; regulatory issues; uncertainty in the outcomes of clinical trials; changes in external market factors; changes in the Company’s business or growth strategy or an inability to execute its strategy due to changes in its industry or the economy generally; the emergence of new or growing competitors; various other competitive factors; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including its Form 10-K/A for the year ended June 30, 2007. Actual results could differ materially from the results referred to in the forward-looking statements. In light of these risks and uncertainties, there can be no assurance that the results referred to in the forward-looking statements contained in this press release will in fact occur. Additionally, the Company makes no commitment to disclose any revisions to forward-looking statements, or any facts, events or circumstances after the date hereof that may bear upon forward-looking statements.

   Company Contact:   James Komorowski   VP, Research & Development   914-701-4500    Investor Contact:   Lytham Partners, LLC   Joe Diaz, Joe Dorame, Robert Blum   602-889-9700  

Nutrition 21, Inc.

CONTACT: James Komorowski, VP, Research & Development of Nutrition 21,Inc., +1-914-701-4500; or Investors, Joe Diaz, Joe Dorame, Robert Blum, all ofLytham Partners, LLC, +1-602-889-9700, for Nutrition 21, Inc.

Web site: http://www.nutrition21.com/

Video: Moms Raise ‘Red Flag’ About the Dangers of Widely Undiagnosed Bleeding Disorder

NEW YORK, Sept. 23 /PRNewswire/ — While an estimated 2.8 million Americans are affected by the most common hereditary bleeding disorder, von Willebrand disease (VWD), most don’t even know they have it. VWD affects both men and women, but according to the Centers for Disease Control and Prevention (CDC) it takes a woman an average of 16 years to receive a diagnosis. Now a group of mothers with VWD have joined together to focus attention on the need for more communication between mothers and their children about signs, symptoms and potentially severe health consequences of this disease.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/vwdmoms/32367/

“Growing up I never knew that what I was experiencing — the bruising and the heavy periods that would last for days — had a name,” said Jeanette Cesta, 45, who wasn’t diagnosed until she was in her 20s. “Because of my diagnosis I was able to ensure that my three children were tested early and received the proper treatment for their VWD.”

The National Hemophilia Foundation’s Project Red Flag campaign, Real Talk About Women’s Bleeding Disorders, educates women about VWD by shining light on the signs and symptoms of the disease which can often present in childhood and puberty. Mothers with VWD are sharing their own stories of diagnosis and treatment to encourage more open communication and family awareness that easy bruising, frequent nosebleeds, and prolonged and heavy menstruation can be symptoms of the disease. Earlier diagnosis is crucial for women with VWD as they are at greater risk for such serious complications as miscarriage, life-threatening bleeding following surgery or childbirth, and undergoing unnecessary hysterectomies, even though their condition can be managed medically.

To help address these issues, The National Heart, Lung and Blood Institute (NHLBI, part of the National Institutes of Health (NIH)) and the U.S. Department of Health and Human Services, recently issued the first-ever clinical guidelines for the diagnosis and treatment of VWD, providing health professionals with evidenced-based recommendations on screening, diagnosis, disease management, and directions for future research.

“Von Willebrand disease can be diagnosed from the patient’s history and the results of blood tests,” said Peter Kouides, M.D, medical and research director of the Mary M. Gooley Hemophilia Treatment Center in Rochester NY. “While there is no cure for VWD, treatment is available and can help prevent complications. But the disorder must be properly diagnosed.”

According to currently available statistics from the CDC, von Willebrand disease affects 1 to 2 percent of Americans. VWD frequently manifests in women as a seemingly gynecological problem, such as heavy or prolonged menstruation. This leads the patient and her doctor to believe the problem is gynecologic. It is, in fact, hematologic, or blood related.

Project Red Flag is NHF’s national public awareness campaign created to educate women and their doctors about diagnosing and treating bleeding disorders, and it is supported by an educational grant from CSL Behring.

“Von Willebrand disease is a serious health issue for women,” said Val Bias, chief executive officer of the National Hemophilia Foundation. “We encourage all women to increase their knowledge of bleeding disorders and to see their doctor immediately if they suspect they have symptoms.”

   Know the Five Signs of a Bleeding Disorder   -- Easy bruising of the limbs   -- Frequent or prolonged nosebleeds   -- Heavy menstrual periods   -- Prolonged bleeding after injury, childbirth or surgery   -- Prolonged bleeding during dental work    

If you have one or more of these symptoms, contact your primary care physician. You may be need to be screened for a bleeding disorder.

For more information on VWD visit the Project Red Flag web site at http://www.projectredflag.org/ or call the National Hemophilia Foundation’s Information Resource Center at 1-800-42-HANDI (email to [email protected]). Trained staff members are available Monday through Friday, 9 a.m. to 5:00 p.m. EST to answer your requests.

About the National Hemophilia Foundation and Project Red Flag

The National Hemophilia Foundation is dedicated to finding better treatments and cures for bleeding and clotting disorders and to preventing the complications of these disorders through education, advocacy and research.

Established in 1948, the National Hemophilia Foundation is a non profit 501(c)3 organization with chapters throughout the country. Its programs and initiatives are made possible through the generosity of individuals, corporations and foundations as well as through a cooperative agreement with the Centers for Disease Control and Prevention (CDC).

For more information about the National Hemophilia Foundation visit http://www.hemophilia.org/.

About CSL Behring

CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients’ lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company’s therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Products include Humate P(R) Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried, Pasteurized, for the treatment of von Willebrand Disease, and Helixate(R) FS a recombinant factor VIII treatment for hemophilia A. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world’s largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.

   Press Contact:   Laura de Zutter   MCS Public Relations on behalf of the National Hemophilia Foundation   1-800-477-9626   John Indence   National Hemophilia Foundation   212-328-3763  

Video: http://www.prnewswire.com/mnr/vwdmoms/32367

National Hemophilia Foundation

CONTACT: Laura de Zutter of MCS Public Relations, for the NationalHemophilia Foundation, 1-800-477-9626, or John Indence of National HemophiliaFoundation, +1-212-328-3763

Web site: http://www.hemophilia.org/http://www.projectredflag.org/http://www.cslbehring.com/

Secrets Most Doctors Aren’t Sharing

BOCA RATON, Fla., Sept. 23 /PRNewswire/ — It’s scary enough that the average doctor’s visit lasts less than 20 minutes, worse still that the time wasted in waiting rooms can easily exceed three times that!

It can be next to impossible to cover every pressing medical concern when everyone is so pressed for time. In the long-run, this “wham bam, thank you ma’am” approach can leave patients clinging to the proverbial short end of the stick.

According to one physician, Traci Ferguson, M.D., a Johns Hopkins graduate and author of the new book, 21 Secrets to Amazing Health, “Doctors know much more about your health than they’re telling you and what they’re NOT sharing could honestly kill you. You can’t afford to be left in the dark when it comes to your health and well-being. Ask those tough questions and demand honest, frank answers from your doctor – don’t be afraid to take control!”

To help patients accomplish this goal, Dr. Ferguson has taken her years of medical training, experience and intimate knowledge of patient administration and advocacy and compiled them together into a 268-page guidebook that puts patient care back where it belongs – in the patients’ hands.

Dr. Ferguson bravely faces tough and touchy subjects ranging from sex to survival to supplements. Entertaining and easy to read, 21 Secrets to Amazing Health offers answers to questions that plague people universally:

   -- Bone loss   -- Blood pressure   -- Diabetes   -- Prostate health   -- Strokes   -- Heart attacks   -- Cholesterol   -- Sex   -- & more    

Dr. Ferguson brings her bedside manner to patients’ bedside tables and unlocks the secrets of longer, livelier living. 21 Secrets to Amazing Health is currently available at Target, Amazon.com and a number of other bookstores both on- and off-line.

About Traci Ferguson, M.D.:

Dr. Traci Ferguson graduated magna cum laude with a Chemistry degree from Georgetown University, then earned her doctorate of medicine from Johns Hopkins University School of Medicine. Graduating with honors at the top of her class, she was inducted into the country’s leading medical honor society, Alpha Omega Alpha. Her residency was completed at world-renowned Johns Hopkins Hospital, and she later served as both a faculty member and clinical instructor at the local university. A board certified Internal Medicine physician, Dr. Ferguson specializes in hospital medicine in Florida where she lives with her husband and son.

   Contact:   Rhadi Ferguson   Ferguson Marketing Systems   (561) 929-8302   [email protected]   http://www.21secretstoamazinghealth.com/    

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com/.

Traci Ferguson, M.D.

CONTACT: Rhadi Ferguson of Ferguson Marketing Systems, +1-561-929-8302,[email protected]

Web site: http://www.21secretstoamazinghealth.com/

Micrus Endovascular Announces Launch of Innovative DeltaPaq Microcoil System

Micrus Endovascular Corporation (Nasdaq:MEND) today announced the initiation of its launch of Cerecyte(R) and stretch resistant versions of its DeltaPaq(TM) microcoil system for the treatment of cerebral aneurysms. The novel DeltaPaq system is designed to achieve 10% to 20% greater intra-aneurysmal packing density than conventional microcoils.

“We are excited about the launch of the DeltaPaq microcoil, designed to enable physicians to achieve greater packing density, which we believe may result in improved outcomes,” commented John Kilcoyne, Chairman and CEO of Micrus Endovascular. “Greater packing density could reduce the rate of recanalization and, therefore, re-treatment. We believe the DeltaPaq microcoil system supplements our framing and finishing coils by materially improving our competitive position in the filling segment of the coil market.”

About Micrus Endovascular Corporation

Micrus develops, manufactures and markets implantable and disposable medical devices for use in the treatment of cerebral vascular diseases. Micrus products are used by interventional neuroradiologists, interventional neurologists and neurosurgeons to treat both cerebral aneurysms responsible for hemorrhagic stroke and intracranial atherosclerosis, which may lead to ischemic stroke. Hemorrhagic and ischemic stroke are both significant causes of death and disability worldwide. The Micrus product line enables physicians to gain access to the brain in a minimally invasive manner through the vessels of the circulatory system. Micrus’ proprietary, three-dimensional microcoils automatically deploy within the aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus also sells accessory devices and products used in conjunction with its microcoils. For more information, visit www.micruscorp.com.

Forward-Looking Statements

Micrus, from time to time, may discuss forward-looking information, including estimated fiscal 2009 revenues. Except for the historical information contained in this release, all forward-looking statements are predictions by the Company’s management and are subject to various risks and uncertainties that may cause results to differ from management’s current expectations. Such factors include the risk of inconclusive or unfavorable clinical trial results, the Company’s ability to obtain, and the timing of, regulatory approvals and clearances for its products, product enhancements or future products, and other risks affecting the Company, including the Company’s involvement in patent litigation with Boston Scientific Corporation, the Company’s limited operating history and history of significant operating losses, fluctuations in quarterly operating results, which are difficult to predict, the Company’s dependence on developing new products or product enhancements, challenges associated with complying with applicable state, federal and international regulations related to sales of medical devices and governing Micrus’ relationships with physicians and other consultants, the Company’s ability to compete with large, well-established medical device manufacturers with significant resources and other risks as detailed from time to time in risk factors and other disclosures in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2008, and other filings with the Securities and Exchange Commission. All forward-looking statements in this release represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intention or obligation to update forward-looking statements.

Beaumont Doctor Invents Device to Improve Blood Clot Treatment Outcomes

ROYAL OAK, Mich., Sept. 23 /PRNewswire/ — The Beaumont Commercialization Center, a medical device development company within Beaumont Hospitals, has a new surgical instrument available for licensing.

Paul J. Arpasi, M.D., a Beaumont radiologist, developed a device that will help reduce the risk for excessive bleeding and infection by allowing multiple catheters or other devices to be connected to a patient from a single puncture site.

When treating a patient, there is often a need to use more than one type of drug or medical device. This creates a need for more than one access site. Any time an access site is used, there is increased risk for excessive bleeding and infection, so it is ideal to keep the number of access sites to a minimum.

This new device has multiple access ports that allow thrombolytic catheters or other devices, such as wires, snares, and low-profile angioplasty balloons to be simultaneously connected to a patient through a single puncture site.

   Multiple simultaneous ports can facilitate:    -- multiple concurrent selective thrombolyses    -- complex foreign body retrieval    -- increased surface area of drug delivery within large caliber vessels    -- multiple low profile angioplasties in patients where multiple access      points are not available    

“The need to insert multiple devices or deliver more than one type of drug to a patient is very common and this invention helps to make that faster, easier, and less invasive,” said Dr. Arpasi. “I’m grateful for the opportunity to improve this procedure and to help in reducing patient’s risk of complications.”

For licensing information, contact Mike Tanner, Director of Technology Development, at (248) 551-0567 or email him at [email protected]. For additional information on this and other licensing opportunities from the Beaumont Commercialization Center, please visit http://www.beaumontcommercializationcenter.com/

About the Beaumont Commercialization Center

Part of Beaumont Hospitals, headquartered in Royal Oak, MI, the Beaumont Commercialization Center is a hospital-based medical device development resource focused on helping manufacturers and inventors bring their ideas for new medical devices and technology to reality. The full-service center blends product development knowledge with the experience of physicians and clinical staff at Beaumont Hospitals.

The Beaumont Commercialization Center offers intellectual property, design engineering, prototype services, usability testing, clinical trials, and regulatory assistance. For more information about the Beaumont Commercialization Center, visit http://www.beaumontcommercializationcenter.com/

Rachael Barnett, (248) 551-8823,

[email protected]

The Beaumont Commercialization Center

CONTACT: Rachael Barnett of The Beaumont Commercialization Center,+1-248-551-8823, [email protected]

Web site: http://www.beaumontcommercializationcenter.com/

Pharmacist With a Heart ; Owner Turns Drugstore into Health-Care Business That Cares

By Tim Rausch

Where else can you get your prescription filled while you play bingo?

As chain-store pharmacies tout soft-drink sales and the latest holiday-related trinkets, Barney’s Pharmacy in south Augusta added a health clinic and a cancer support group.

It hasn’t been Barney’s pharmacy in decades. It is Barry’s, but Barry Bryant never had any intention of changing the name.

In 1984, an agreement to fill in part time for the Peach Orchard Road pharmacy put Mr. Bryant on the road to ownership. Only three years out of pharmacy school, he left a Kroger store for the uncertainty of an under-performing independent pharmacy.

Almost a quarter of a century later, Mr. Bryant has a small empire of medicine under way in the shopping center in the 2700 block of Peach Orchard.

More than a year ago, Hope Medical opened as a medical clinic attached to the rear of the pharmacy. A few doors down is MedEquip Healthcare, his medical equipment company.

“I tried to create a one-stop shop,” Mr. Bryant said.

Those making the stops are people attending diabetes classes or playing bingo on Friday mornings. Barney’s pharmacy fills 1,000 prescriptions a day, some of them delivered.

Just five years ago, the pharmacy had a fraction of the staffers – now there are 60 – and one cash register – now there are five.

“Anything he touches. … I don’t know how he does it, but he does it,” said daughter Vanessa Hoffman, who works at the pharmacy.

All three of Mr. Bryant’s daughters are following in his footsteps – except they’re getting their education at the University of South Carolina. That was initially a tough pill to swallow for the University of Georgia graduate.

The upstairs conference room is Bulldog territory. The walls are team colors. He has pictures of six Uga bulldog mascots on the wall, hanging above the ceramic bulldog bigger than his chest.

With three daughters going through the doors of the sporting rival, Mr. Bryant has been converted to a Gamecocks fan – except for the day they play Georgia.

The biggest joke in the pharmacy is Mr. Bryant’s “day off” on Thursdays.

“He’s here six days a week, church on Sunday, that’s his life,” Mrs. Hoffman said.

If he’s not at Barney’s, he is visiting two other pharmacies where he shares ownership: Medical Center Pharmacy in south Augusta and Medical Center West Pharmacy in Evans.

There’s another store in the works, set to open somewhere in Grovetown next year. That one will be called Barney’s.

A name

The real Barney was Barney Crouch, who died in October 1984, just weeks after Mr. Bryant took over the store that bears his name.

Mr. Bryant worked along side Mr. Crouch for a time in 1980. Mr. Bryant was doing an internship rotation on his way to obtaining his pharmacy degree from the University of Georgia. Mr. Crouch was the pharmacist at Shoppers Drug Mart in Regency Mall.

“This guy, even though he was working for a chain, people came in with sore throat … he would mix something up. He had his own concoction for everything,” Mr. Bryant said. “People loved that. People come in here today and ask if we still make Barney’s special gargle, poison ivy cream. And we do.”

Three years later, when Mr. Bryant was offered part ownership in Barney’s Pharmacy, he had a thought of getting Mr. Crouch back into the store with his namesake. That chance never came.

“We kept the name the same. People ask me why don’t you call it Barry’s? Because everyone knows Barney’s,” Mr. Bryant said.

Mr. Bryant said Mr. Crouch was one of those pharmacists who had a love for people and tried to help each customer in a special way. It is that philosophy that continues today under Mr. Bryant’s ownership.

That ownership was a chance call during Mr. Bryant’s third year on the job at Kroger in Martinez. He was the pharmacist in charge.

A pharmacist who works at Barney’s called him to ask whether he could fill in the next day. Mr. Bryant had the day off, so he agreed to help out.

“He left the keys to the store in the mailbox,” he said. “This is a guy who never met me.”

He and one employee ran the store for the day. He recalled filling about 30 prescriptions.

Mr. Bryant filled in a few more times and then got a call from the owner, asking whether he would consider leaving Kroger. He was offered ownership in half of the business.

“I was thinking, the store wasn’t doing well. It had no computer and one employee,” Mr. Bryant said.

It also represented a $200 a week cut in pay to jump ship.

“The proposal was half of the business. Half of nothing that was half of an opportunity to make something. And that is what I saw,” Mr. Bryant said.

Even his store manager at Kroger thought it was a good idea. He left on good terms in case he had to return to the grocery chain if it didn’t work out.

Barney’s Pharmacy was in Chapter 11 bankruptcy at the time.

“I had to go down to the courthouse for the reorganization plan. Never been to court in my life.”

Mr. Bryant said they saw the new blood in the business, the young kid that was going to turn it around.

Five years later, all the debtors had been repaid.

Mr. Bryant said he wrote down the amount of business done in 1984. It was $284,000 for the entire year.

“We’ll do that business in a week now.”

A history

Mr. Bryant is the oldest of four, and the only son, born to Ernest and Dorothy Bryant. He was born in Augusta in 1959, but moved to Louisville, Ga., at age 10 when his parents separated.

His mother was a cosmetologist who ran a personal-care home out of her house for a handful of elderly people.

“You see the influence I had going back. She had four elderly ladies that lived in the house with us in the back. She cooked for them, helped them to the bath room, took them to the doctor. As well as raising us,” Mr. Bryant recalled.

His father was a chemical operator for Dupont at Savannah River Site. He retired after 40 years.

Living in Louisville, Mr. Bryant helped his father raise cows and pigs on the farm. He also helped with his uncle’s farm over the summer. It was that exposure to agriculture that gave him thoughts of agriculture at college. The reaction was:

“If you want to be a farmer, you can stay here and learn all that.”

Mr. Bryant went to college in Athens with a computer science degree in mind. Computers had been making a surge in the late 1970s and he wanted to become a programmer.

He enjoyed science in high school, anyway.

That was altered by a change of roommates – his first one dropped out after a family member died. He was then paired with a senior pharmacy student from Augusta.

“He was telling me about his classes and what he was reading,” Mr. Bryant said. Because he was already in a bachelor of science track, he needed only a few classes to fulfill pre-pharmacy school requirements. He was accepted, and a year later was on the road to become a pharmacist.

He was also the only person in his family to go to college. He did it on student loans and help from his parents and grandparents.

“When he wrote me that check for $100 to buy books and eat on that week, with what he made, I don’t know how he did it,” Mr. Bryant said of his father.

Mrs. Hoffman, the eldest daughter, said her father’s being the only college-educated member of his generation never manifested itself into forcing his daughters to go to college.

“Don’t rely on a man supporting us; we can support ourselves, is the way he always told us,” she said. “That was the way he was raised.”

Mr. Bryant’s first job out of college was the Kroger store on Columbia Road in Martinez in 1981.

It was there that he met Charlene, who worked in the front office and would marry him two years later.

“Once we got married, they moved her to another store, so we didn’t get to work together,” Mr. Bryant said.

A blessing

Barney’s was much smaller six years ago. It had a dozen employees and a single cash register. It did an average number of prescriptions compared with other independent pharmacies – 200 a day.

Mr. Bryant recalls meeting a greeter at church one night and being told he had a message from an evangelist on a local television station. There was a local business, a pharmacy, that the Lord was going to bless and it was going to flourish.

Mr. Bryant took in the message, not having seen the TV program. Others would come up to him in the following days after having seen that program – they all thought of him. They believed the message was about Barney’s Pharmacy, they said.

Six years later, Mr. Bryant believes it, too.

“Looking back at where we came from to where we are today, it is amazing,” Mr. Bryant said. “We have a $200,000 robot down there that was given to me. How else does that happen?”

The robot was a gift from University Hospital. It spends all day dispersing the most common medications.

The acceleration of business success began in the mid-1990s.

Mr. Bryant tapped a Kroger pharmacist, Kyle Pulliam, to fill in on Peach Orchard Road in the late 1980s. It was just coincidence that Mr. Pulliam happened to work in the same Kroger pharmacy that Mr. Bryant once ran. It was an eerily similar twist of fate that this Kroger pharmacist would be offered a businesses partnership just as Mr. Bryant was.

Mr. Bryant’s offer to Mr. Pulliam was a partnership in a new pharmacy that University Hospital wanted to put in its prompt care on Peach Orchard Road. Medical Center Pharmacy was born in 1995.

Mr. Bryant said it was better to start a new pharmacy than try to move Barney’s.

Mr. Pulliam and Mr. Bryant teamed up again in 2003 for Medical Center West Pharmacy, which started out as the University Hospital employee pharmacy on Columbia Road. There was still walk-in business there when the hospital employee concept moved, Mr. Bryant said.

The pharmacy moved a few times too, now situated within University’s medical complex on Belair Road in Evans.

“We’re in a building with 30 doctors, right in the middle of a beehive there,” Mr. Bryant said. “Even though they’re not called Barney’s, we do things the same way.”

They are also partners in MedEquip Healthcare. That idea came from customers’ constant inquiries into walkers and wheelchairs and hospital beds.

“I was the best ad for A-Plus and Duramed,” Mr. Bryant said. In 2000, he hired an office manager and a man with medical equipment experience and placed the new company next to Barney’s.

It started slowly, Mr. Pulliam said, but it blossomed. It now has 10 employees. The company handles everything from power lifts to braces, canes and power wheelchairs.

Mr. Pulliam said his partner is an innovator.

“He does have ideas. I don’t know if he does a lot of reading or if they are off the top of his head,” he said. “The clinic was a tremendous idea.”

A leap of faith

Mr. Bryant did something nearly two years ago that he never envisioned doing. He went into debt for $1 million.

The money went for the purchase and renovations of where Barney’s sits now, which is larger than the adjacent older store. More importantly, it went to create Hope Medical, an ambulatory care center that is more like a family doctor center than a prompt care.

Mr. Bryant was already steadily adding more scopes of service to his pharmacy, a breast cancer support group and healthy heart and diabetes classes. He wants to add a support group for stroke victims too.

“It is about caring about the patients’ health. We get involved with their health care as much as they want us to be involved,” he explained.

The clinic opened in April 2007. It averages 25 patients a day.

Setting it up seemed as though something divine was guiding it, Mr. Bryant said. New X-ray equipment was found from a doctor closing his practice, he said.

Mr. Bryant said the initial plan was to convince a doctor to move in next door. No one signed on to do it, so he went with the idea himself, hiring nurses and physician assistants and finding a medical director.

He doesn’t see the clinic as competing with family doctors, but there is so much business out there from people who don’t have one.

“We’re trying to keep folks from falling through the cracks.”

That includes education. He said half of the people who walk into the pharmacy are diabetic.

They have classes twice a month in the attached meeting room. One of the pharmacists is a certified diabetes educator, something rarely seen outside of hospitals.

Mr. Bryant said he wants Barney’s to become American Diabetes Association-certified in order to bill people’s insurance for the time they spend educating.

Diabetes is a topic that runs close to Mr. Bryant’s heart. His mother died of complications from the condition.

“I remember her taking insulin shots,” he said. “If someone was able to educate her then and help her get her sugar where it needed to be, my mom would still be here today.”

He lost a father-in-law to diabetes, too.

“People did what they wanted and ate like they wanted because they felt fine. When the complications catch up to you, it is too late, the damage is already done.”

Barney’s has fun every Friday morning when more than 40 people pile into the wellness classroom for bingo. There are prayer, dancing and prizes, at no charge.

“It costs money to do things like that. We don’t do it to make money. But it really helps grow the business. People feel you care about what you’re doing,” Mr. Bryant said.

He said his business smarts come from on-the-job training. Up until a few years ago, he did the payroll, too.

If he plays golf twice in one month, it is a lot. Mrs. Hoffman said work is her dad’s life.

“He’s business-driven; that’s where his heart is.”

A future

Two pharmacy students from the University of Georgia started working in Barney’s this month. They are doing their rotations – on- the-job training – that are needed before becoming board certified. Mr. Bryant gets two to five students a month from either Georgia, University of South Carolina or the Medical University of South Carolina.

“They’re pharmacists, they just don’t have their license yet. Getting the hands-on clinical experience. That’s an asset for us, no pay but they’re here to serve people,” he said. “Carolina has reached out to us, really interested in what we do here.”

The pharmacy dean and faculty have toured the pharmacy and seen what he’s doing as the cutting edge of pharmacy. Classes cite what he’s doing.

He has also funded endowments to aid in the education.

Students going through Barney’s can spend time in the compounding area, where the pharmacy makes special items such as tetracaine (anesthesia) lollipops. They can also spend a month on the retail line or ambulatory care at Hope Medical.

Mr. Bryant said he hopes some of the information being gathered in Hope Medical by the pharmacy students can be published in a journal.

Mrs. Hoffman did her training this way, though the clinic wasn’t there when she was still in school. Her interest in pharmacy was piqued much earlier. She started working with her father when she was 13 years old, coming down to the pharmacy on Saturdays.

“I told my mom then that I wanted to go to pharmacy school,” she said.

Stephanie and Brittney Bryant are also in pharmacy school. They will join their father in the business after their training is finished.

Mrs. Hoffman sees an equal partnership in the business among the family one day.

“I couldn’t think of a better person to be in business with,” Mr. Pulliam said. “He’s a Christian guy that walks the walk and talks the talk.”

Mr. Bryant has never been on a mission trip, though his wife has taken them to Costa Rica and Mexico.

“He helps support them, donates as much as he can to those causes,” Mrs. Hoffman said.

Mr. Bryant said he’s given inoculations for free for those going to foreign lands.

“Not everyone is called to go. I don’t think the Lord is calling me to Africa,” Mr. Bryant said. “Where I come in is to help those that are called to go.”

Mr. Bryant sits on the board for The Sanctuary church on Cox Road in Evans. It has been there two years now. A parking lot is being renovated and soon a project will start for a new sanctuary to sit more people – room for 1,000.

He also sits on the board of the CSRA Partnership for Community Health, which runs indigent care clinics on Druid Park Road and Golden Camp Road. His role in helping the indigent is reduced cost prescriptions, for a $5 co-pay, for the people who come through those clinics.

“My girls were raised going to church … I’m trying to instill in them why we’re doing this. In the long run, helping these folks will come back,” Mr. Bryant said. “This is something my girls can take and continue the legacy.” \

BARRY BRYANT

BORN: July 13, 1959, Augusta

TITLE: Owner, Barney’s Pharmacy; co-owner, Medical Center Pharmacy and Medical Center West Pharmacy

EDUCATION: University of Georgia, bachelor of pharmacy, 1981

FAMILY: Wife, Charlene; daughters, Vanessa, Stephanie and Brittney

HOBBIES: Occasional golf\

Reach Tim Rausch at (706) 823-3352or [email protected].

Originally published by Tim Rausch Staff Writer.

(c) 2008 Augusta Chronicle, The. Provided by ProQuest LLC. All rights Reserved.

Living With Psoriasis

By Cornish, Linda Kleinstein, Susan

Dermatology nurses and other health care professionals may sometimes fail to appreciate and recognize the physical and emotional challenges faced by patients with a particular chronic dermatologic disease or condition. “Patients’ Perspectives: Living with…” series shares these important patient views and comments to improve patient care. If you know of a patient who would be interested in sharing his/her experiences with the dermatology nursing community, please ask him/her to briefly answer (3-5 sentences) the questions as outlined here. Submissions can be sent via e-mail to the journal office at [email protected] or mailed to Patients’ Perspectives, Dermatology Nursing, East Holly Avenue Box 56, Pitman, NJ 08071-0056. Patient #1:

55-Year-Old Male

When were you diagnosed with your disease/condition?

I was diagnosed approximately November 2006.

When and how did you find out you had the disease/ condition?

I had an outbreak of skin plaques.

How would you describe your appearance?

Currently, there is some discoloration spots throughout my body.

What kind of education and support were you given at the time of your diagnosis?

Discussions with my dermatologist and through handouts. I also read a lot online at psorisasis.org

How has your disease/condition affected your life, physically and emotionally?

The disease absorbs time in my maintenance routine. I wish I didn’t have it, but I have not let it have a significant impact otherwise on my activities. I also spend more time on my fitness.

What would you like health care providers to know about treating people with your disease/condition?

More time with MD consult, and observation of skin condition.

What worked for you and what didn’t (treatments, emotional support, etc.)?

My current regimen is UVB and salt bath, at a lower dose.

What do you wish society knew about your disease/ condition?

That psoriasis is not contagious.

What would you tell other people who are newly diagnosed with this disease/condition?

Make yourself as comfortable as possible, so you can rest. Appearance is secondary. Also, buy a handheld UVB device.

How do you think living with this disease/condition will affect your life in the future?

My first year I was not so sure. I believe it will make me more conscience of my health. It will make older life more complex.

Patient #2:

65-Year-Old Female

When were you diagnosed with your disease/condition?

When I was 20 years old, 1962. I had just begun teaching junior high school in the South Bronx in New York City. It was very stressful.

When and how did you find out you had the disease/ condition?

I developed redness and itchy spots, mainly on the knees and elbows. I don’t recall if the doctor I saw was my general practitioner or a dermatologist, but I was told it was psoriasis.

How would you describe your appearance?

My skin is mostly clear now.

What kind of education and support were you given at the time of your diagnosis?

Very little. I was prescribed some skin salve. I don’t remember more.

How has your disease/condition affected your life, physically and emotionally?

In the past, I avoided short-sleeve tops and preferred pants or stockings to cover the spots. I was self-conscious about them. Now, I have no restrictions and no problems.

What would you like health care providers to know about treating people with your disease/condition?

I would like them to follow the Kaiser model. My care there has been excellent. Also, they should all know about the National Psoriasis Foundation (NPF), which gives excellent information and support.

What worked for you and what didn’t (treatments, emotional support, etc.)?

Some creams, such as clobetasol, Dovonex(R), Cyclocort(R). But the best is phototherapy, which I get once a week at Kaiser and which has kept my skin clear. It doesn’t help my scalp but the problem there is minimal.

What do you wish society knew about your disease/ condition?

That psoriasis is not contagious, and that people with psoriasis should be accepted for who they are. I’m lucky my case is mild and I have great sympathy for those who suffer more.

What would you tell other people who are newly diagnosed with this disease/condition?

That although there is currently no cure, this is being worked on, and many treatments are excellent. Try what works for you (phototherapy, creams). Seek out the support of NPF and find others for mutual support through the NPF.

How do you think living with this disease/condition will affect your life in the future?

I don’t see any problems. I do go to dermatology treatments weekly for phototherapy and this takes time. Also, I’ll choose to live near a Kaiser facility that offers this treatment, but I don’t plan a move.

Ask Your Patients to Participate in

“Patients’ Perspectives: Living With…”

Dermatology nurses and other health care professionals may sometimes fail to appreciate and recognize the physical and emotional challenges faced by patients with a particular chronic dermatologic disease or condition. To better bring patients’ feelings and perceptions into focus, the Dermatology Nursing Editorial Board is introducing a new series, “Patients’ Perspectives: Living With…,” and we need your help.

If you know of a patient who would be interested in sharing his/ her experiences with the dermatology health care community, please ask him/her to briefly answer (3-5 sentences) for each of the following 10 questions.

1. When were you diagnosed with your disease/condition?

2. When and how did you find out you had the disease/condition?

3. How would you describe your appearance?

4. What kind of education and support were you given at the time of your diagnosis?

5. How has your disease/condition affected your life, physically and emotionally?

6. What would you like health care providers to know about treating people with your disease/condition?

7. What worked for you and what didn’t (treatments, emotional support, etc.)?

8. What do you wish society knew about your disease/condition?

9. What would you tell other people who are newly diagnosed with this disease/condition?

10. How do you think living with this disease/condition will affect your life in the future?

To put a “face” on these insights, we also ask that patients include a color photo (headshot) of themselves. (Photos are optional; names will also be withheld upon request.) Our goal is that these important patient views and comments will improve patient care. Please consider asking interested patients to share their perspectives with dermatology nurses.

Submissions can be sent via e-mail to the journal office at [email protected] or mailed to Patients’ Perspectives, Dermatology Nursing, East Holly Avenue Box 56, Pitman, NJ 08071-0056.

Thank you for helping us in our efforts to improve dermatologic patient care.

Linda Cornish, RN, is a Staff Nurse II, Dermatology Clinic, Kaiser Permanente, Oakland, CA.

Susan Kleinstein, RN, is a Staff Nurse II, Dermatology Clinic, Kaiser Permanente, Oakland, CA.

Copyright Anthony J. Jannetti, Inc. Aug 2008

(c) 2008 Dermatology Nursing. Provided by ProQuest LLC. All rights Reserved.

Accurately Diagnosing Commonly Misdiagnosed Circular Rashes

By Popovich, Debbie McAlhany, Allison

Rashes are common in the pediatric population yet can be quite problematic for nurse practitioners to diagnose. A thorough history and physical examination, along with some simple procedures, will aid in identifying these skin conditions. Four cases are presented, which may initially prove challenging to diagnose, and symptoms are categorically examined to arrive at the accurate diagnoses. Treatment guidelines, options, and the role of parental education and involvement also are discussed. Skin lesions are common and encountered in all pediatric practice environments. It is therefore important to understand the fundamentals of diagnosing common skin conditions, appropriate therapy, and parental education. Rashes in children can affect their daily lives by exclusion from school or daycare. Parents who are required to miss work while awaiting proper diagnosis and treatment contribute to the financial burden of these commonly seen and easily treatable skin conditions. Infections such as tinea and impetigo may stigmatize children and their family due to their communicability and appearance. Several of the rashes presented can be spread among children and their playmates, classmates, and family members. Early access to treatment can avoid this transmission and further reduce the financial impact. In this era of rising methicillin-resistant Staphylococcus aureus (MRSA) rates, prompt treatment of infectious skin rashes may reduce the potential progression to bacterial infections and ultimately decrease cost and social handicap. Differentiating between rashes with similar presentation is essential for the astute pediatric nurse practitioner.

Four Cases Involving Circular Rashes

Case 1 (Granuloma Annulare, see Figure 1). A 2- year-old boy presents with a circular lesion, which he has had for over 6 months, on the dorsal aspect of the left foot. The mother believes it may be spreading, having noticed the development of a second lesion just above the first. The child has given no indication that the lesions are irritating or pruritic, and no other family members have similar lesions.

Case 2 (Bullous Impetigo, see Figure 2). A 6-yearold boy presents with multiple lesions on both elbows and hands. They are pruritic and increasing in number. Each lesion forms a blister. The family denies noticing any fluid when the blisters rupture.

Case 3 (Tinea Corporis, see Figure 3). A 5-year-old girl presents with a 2-day history of circular rash on her anterior lateral thigh. She was recently seen by a pediatric nurse practitioner for her routine wellness examination and appeared symptom free at the time.

Case 4 (Tinea Capitis, see Figure 4). A 4-year-old female presents with a 1-week history of hair loss in the left temporal region.

Differential Diagnoses

Cases 1 and 2 demonstrate a lengthy list of possible diagnoses, so it is prudent to begin by evaluating for the most common presenting skin infections in childhood. Potassium hydroxide (KOH) scrapings are essential to rule out tinea as the cause of annular lesions based on the frequency of diagnosis. Cultures of fluid- filled lesions will determine the causative organism, be it viral (such as HSV) or bacterial (such as S. aureus). See Table 1 for differential diagnoses for annular lesions of the head and Table 2 for differential diagnoses of annular lesions of the body.

Granuloma Annulare

Although often confused with tinea corporis, the correct diagnosis in this case is granuloma annulare. A KOH scraping may help differentiate the two in the clinic setting. Granuloma annulare is a self-limiting inflammatory skin lesion occurring in both adults and children (Barron, Cootauco, & Cohen, 1997).

Diagnosis. These lesions are often seen on the hands, arms, and ankles. Granuloma annulare is characterized by rings of closely set, small, smooth, firm papules, usually skin colored, but they also may be slightly erythematous or have a purplish hue. Lesions vary in size from 1 cm to 5 cm. They are generally asymptomatic and nonpruritic (Fairlie, 2004). Reports of associations between granuloma annulare and diabetes mellitus, thyroid disease, malignancies, drug allergies, hypertension, arthritis, AIDS, and other conditions are being evaluated, but to date, no consistent association has been found (Rigopoulos et al., 2005). Thus, what causes these types of lesions remains unknown although evidence exists that they generally regress on their own within 2 years (National Institutes of Health, 2004).

Treatment. Several treatment options exist with varying success. The current consensus is that no treatment is necessary because this skin eruption is generally asymptomatic and self-limiting (Felner, Steinberg, & Weinberg, 1997; Kowalzick, 2005). Treatment options for those concerned with the cosmetic aspect of the condition include topical steroids, ultraviolet light (Schnopp et al., 2005), and cryosurgery (Blume-Peytavi et al., 1994). Several newer treatment options have been studied with small sample sizes that demonstrated promising results, including pimecrolimus 1% (Rigopoulos et al., 2005), tacrolimus 0.1% (Jain & Stephens, 2004), vitamin E (Burg, 1992), and others. Although lesions may improve with intervention, recurrence is common with or without therapy. Additional studies are needed to further investigate the efficacy of these interventions.

Parental role. Parents should continue to assess the lesions and prevent irritation and potential infection with the use of clothing barriers such as socks, long sleeves, and pants.

Impetigo

Impetigo is a common and highly contagious pediatric skin infection. Intact skin is an effective barrier that decreases the risk of infection. When the child scratches a lesion, bacteria are introduced, causing inflammation and infection. This infection is most commonly seen in children aged 2 to 5 years but can occur at any age. Impetigo may be bullous or nonbullous and is usually caused by Staphylococcus aureus or Group A beta-hemolytic streptococci (GABHS) organisms.

Diagnosis. Although it was once thought that the organism causing impetigo could be predicted based on its bullous or nonbullous honey- colored crusted appearance, there is some evidence indicating that lesions may be affected by (or associated with) both S. aureus and GABHS (Stulberg, Penrod, & Blatny, 2002). The bullous form of impetigo presents as a large, thin-walled bulla (2 to 5 cm) containing serous yellow fluid. It often ruptures, leaving a complete or partially denuded area with a ring or arc of remaining bulla (Stulberg et al., 2002).

Treatment. Localized areas of impetigo are most commonly treated with antibacterial ointment such as 2% mupirocin (Bactroban(R)) cream or ointment. This preparation covers the organisms responsible for impetigo: GABHS, methicillin-sensitive S. aureus (MSSA), and MRSA. Oral antibiotics that cover gram-positive skin organisms, such as first generation cephalosporins, should be started if widespread impetigo is present or if localized lesions do not improve with topical medication. When an oral antibiotic is used, the additional use of mupirocin is not necessary to eradicate the bacteria (Bell, 2002). Topical bactericidals may decrease dissemination to other vulnerable individuals. It has also been suggested that oral antibiotics should be seriously considered when lesions occur near the patient’s mouth, since a topically applied antibiotic may be frequently licked off, especially by younger patients (Bell, 2002).

Lesions that do not improve with oral medications should be suspect for community-acquired MRSA and cultured to identify the organism responsible and determine sensitivity. In the event of community-acquired MRSA, evaluating the sensitivity will allow the practitioner to make the best treatment choice for the patient. Trimethoprim-sulfamethoxazole (Septra(R)) should not be considered a firstline treatment (without MRSA positive cultures and demonstrated sensitivity) due to potential risk of Stevens-Johnson syndrome and increasing resistance to S. aureus from overuse of antibiotics. Practitioners should be aware of MRSA rates in their communities when considering the best course of action.

Potential but uncommon complications of impetigo include cellulitis, superinfection, and acute poststreptococcal glomerulonephritis (APSGN), but outbreaks of impetigo do not result in rheumatic fever (American Academy of Pediatrics [AAP], 2003; Kaplan, 2005). Prompt treatment of GABHS infections does not decrease the incidence of glomerulonephritis (Pichichero, 1998). APSGN can occur approximately 2 weeks after impetigo infections due to nephritogenic strains of GABHS. This post-streptococcal illness is the consequence of the host’s immune response to a non-renal infection. Although this process is not fully understood, antigenic mimicry may be the triggering factor, leading to autoimmunity (Hahn, Knox, & Forman, 2005). Patients with any type of streptococcal infection should be monitored for decreased urine output, tea- colored or dark urine, headache, nausea, vomiting, and evidence of edema. Physical examination may reveal hypervolemia, edema, or hypertension. Although rare, parents should be alerted to this possible complication and the accompanying symptoms.

Parental role. Parental education is paramount in the prevention and successful treatment of impetigo. Children’s fingernails should be kept clean and short, and antibacterial soap used at the first sign of altered skin integrity. Nasal S. aureus has been implicated in recurrent impetigo (Raz et al., 1996), so parents should consistently encourage the use of tissues and handwashing. Children infected with impetigo should not bathe together, share towels, or have skin-to-skin contact. Topical treatment of Bactroban is applied three times a day for 7-14 days. Over-the-counter Neosporin may be effective for impetigo if MRSA is not involved. If the infection does not improve in 14 days or worsens despite therapy, children should be evaluated by their health care provider. Tinea Infections

Dermatophyte (tinea) infections are the most common recurrent and persistent fungal infections of the hair, skin, and nails in children of all ages. In the United States three types of dermatophytes account for the majority of fungal infections: Trichophyton, Epidermophyton, and Microsporum. Tinea corporis can be caused by any of these dermatophytes (Rinaldi, 2000; Tosanger & Crutchfield, 2004). The source of transmission is direct contact with humans, animals, or fomites infected with the organism. Greater than 90% of tinea capitis infections are caused by Trichophyton tonsurans (Schwartz, Bell, Bingham, Chung, & Cohen, 2003). Cats and dogs are a major source of Microsporum canis.

Diagnosis. On physical exam, tinea corporis presents as a circular or oval erythematous scaling lesion, hence the term “ringworm.” The circular area has a pale center with mildly erythemic raised borders due to inflammation. The interior is dry, scaly, and may be pruritic. The affected area may closely resemble other dermatologic conditions that can manifest as round patches or plaques such as pityriasis rosea, nummular eczema, granuloma annulare, psoriasis, tinea versicolor, and annular contact dermatitis.

Children exposed to the dermatophytes may be at increased risk of infection if they are immunocompromised, have areas of skin trauma, or remain in moist and/or occlusive clothing. Once the organism has invaded the stratum corneum, the central clearing of the infected site will occur in a few weeks, resulting in the pathognomonic appearance.

History taking includes the onset, duration of infected areas, any changes in appearance over time, and any prior treatment and its effectiveness in relieving symptoms. Assessment of changes in children’s scalps, hair, nails, and mucous membranes, plus queries about the health of the family’s pet(s) and interactions between pet(s) and children, should be ongoing.

The diagnosis of tinea corporis usually is made by visual assessment, but the diagnosis can be augmented by microscopic examination. The erythematous border is the active area and the ideal spot for obtaining scrapings. The scaling border is scraped with a blade. The material is placed on a glass slide with one drop of 10% KOH, allowed to dry, and a cover slip is placed on the slide. Branching hyphae are characteristic.

Treatment. Solitary or non-inflammatory lesions are treated with twice-daily applications of the topical class of imidazoles such as 1% clotrimazole and 2% miconazole. Ketoconazole 2% is applied once daily. Treatment should last for 2 to 4 weeks or 2 weeks beyond when lesions have disappeared, not merely when the lesions have resolved or are no longer pruritic (Wichmann, 1994). Burning, itching, and stinging may occur as a result of local irritation. Steroids can act like fertilizer and actually increase tinea growth. Alston, Cohen, and Braun (2003) found the use of combination clotrimazole 1% cream/ betamethasone diproprionate 0.05% cream (Lotrisone(R)) to be associated with persistent/recurrent tinea corporis infection. “Tinea incognito” is the term applied to tinea corporis lesions that have undergone topical steroid treatment and are no longer red and scaly, making typical presentation unlikely and difficult to diagnose (Hines & Paniker, 2005). Parents should be instructed to apply the antifungal cream as often as prescribed (typically in the morning and evening for twice daily dosing) and after swimming, bathing, or play/exercise. Pets should be examined by a veterinarian. Normally, children can return to daycare or school without threat of transmitting the infection after topical treatment has begun (Wichmann, 1994).

Extensive, highly inflammatory lesions or those that do not respond to topical treatment usually require systemic therapy. Griseofulvin is an antifungal antibiotic produced by a species of Penicillium, administered orally, and is effective against dermatophytes only. It remains the drug of choice for tinea corporis (AAP, 2003). Its effectiveness on superficial fungal infections lies in its ability to penetrate keratin precursor cells. This creates an unfavorable environment for hyphae to reproduce, thus facilitating the exchange of infected skin cells for those not infected with the dermatophyte. For children over 2 years of age, the AAP recommends a dose of 10 to 20 mg/kg/day (maximum: 1 g) of microsize griseofulvin given in one to two divided doses. Dosages up to 20 to 25 mg/kg/day have been used (AAP, 2003). The suggested therapy length is 2 to 4 weeks.

Nurse practitioners must carefully consider the child’s medical history for contraindications to the use of griseofulvin, such as hepatic disease, pregnancy, and systemic lupus erythematosus. Practitioners also should use caution when prescribing griseofulvin in a patient with a history of penicillin hypersensitivity. The hepatic metabolism of estrogencontaining oral contraceptives can be accelerated by griseofulvin, rendering them less effective. Female adolescents must be instructed to use a back-up method of birth control while taking the antifungal and for 1 month after it is discontinued (Archer & Archer, 2002). Due to potential harmful effects on human sperm, it is recommended that males wait at least 6 months after completing griseofulvin treatment before attempting to father a child (Grifulvin V, 1982). In addition, the excretion of griseofulvin in breast milk has not been well documented; possible effects on breast-feeding infants are unknown, thus breast-feeding is not recommended during use (Griseofulvin, 2006). Food also can affect the medication’s bioavailability (Schmidt & Dalhoff, 2002). The absorption of microsized griseofulvin may be enhanced by the intake of food high in fat such as whole milk, ice cream, cheese, and peanut butter. It also may induce photosensitivity, requiring extra sunscreen or protective clothing in intense sunlight. Tanning beds are absolutely contraindicated.

Parental role. In addition to topical and systemic medication, there are practical interventions to be discussed with the parents or guardians. These include keeping the infected area clean and dry. Wet, damp, or tight-fitting clothing should be avoided. Clothing or linen having contact with the infection should be washed. Fingernails need to be kept clean and trimmed short to prevent secondary bacterial infections.

Tinea Capitis

T. tonsurans (the most common cause of tinea capitis) and M. canis account for the majority of tinea capitis infections in the United States and Europe (Chan & Friedlander, 2004). T. tonsurans is associated with human-to-human contact and with fomites such as combs, hats, seatbacks, and telephones. An endothrix, T. tonsurans’ growth and spore formation is largely confined to the hair shaft, where the spores increase hair follicle fragility.

Diagnosis. In non-inflammatory tinea capitis, the hair breaks off just above the level of the scalp. The black tips of the hair follicles remain, causing the typical black-dot appearance. Another common presentation resembles seborrheic dermatitis; the scalp appears scaly rather than blackdot. This inflammatory type of tinea capitis is characterized by pustules, papules, and crustiness of the scalp. Cats and dogs are natural reservoirs of M. canis fungal infections of the commonly inflammatory type. Infected cats contaminate the environment with microsporum through airborne arthrospores. Dogs are more likely than cats to contaminate surfaces and are less likely to cause infections in humans (Mancianti, Nardoni, Corazza, D’Achille, & Ponticelli, 2003). The organism is transmitted through direct contact of an exposed area such as the face, scalp, or arms, with an infected animal or its dander (Fitzpatrick, Eisen, Wolff, Freedburg, & Austin, 1993). The spores of M. canis, an ectothrix, grow on the outside of the hair shaft and produce a substance that fluoresces green under a Wood’s lamp. This aids in the species diagnosis (as T. tonsurans does not fluoresce).

Correct and early diagnosis of tinea capitis is necessary to prevent significant hair loss, scarring, and pain. The evidence of hair loss or scaling on the scalp of any child is suspect for this fungal infection. Other common skin infections frequently mistaken for tinea capitis (resulting in delay of correct treatment) are seborrheic dermatitis, atopic dermatitis, trichotillomania, alopecia areata, psoriasis, folliculitis, and impetigo. In a study of 100 children presenting with at least one fungal symptom indicative of tinea capitis, Hubbard (1999) found that abnormal enlargement of the lymph nodes (lymphadenopathy) had the highest positive predictive value. Definitive diagnosis is made by KOH preparation or fungal culture. If the provider is unskilled in KOH interpretation, a fungal culture may be obtained in one of three ways, although the first two methods, hopefully archaic by now because of unnecessary discomfort for children and families, involve plucking hairs or scraping the scalp with a blade. Friedlander, Pickering, Cunningham, Gibbs, and Eichenfield (1999) found a third method of obtaining a specimen that was easy, reliable, inexpensive, and painless. A cotton swab moistened with tap water is rubbed against the infected area and plated on fungal culture medium. The swab specimen may also be inserted into a culturette system and transported to a laboratory. According to Friedlander’s (1999) study, both in-office and laboratory cultures showed the same results. Treatment. Griseofulvin is the drug of choice for tinea capitis, either as a dose of microsized liquid (20-25 mg/kg/ day in a single dose) or divided into two daily doses for children over 2 years of age (Chan & Friedlander, 2004; Elewski & Krowchuk, 2001). Heightened photosensitivity associated with griseofulvin can be reduced by once daily dosing with the evening meal (Silverman, 2001). Treatment is for 4 to 8 weeks (or longer as needed) until the symptoms are resolved and the organism eradicated. Higher dosing and duration of treatment may result in increased noncompliance as children experience the side effects of headache, nausea, and diarrhea. Therapeutic alternatives to griseofulvin include terbinafine or fluconazole. Friedlander and colleagues (2002) found that when efficacy, cost, and compliance were taken into consideration, 2 weeks of terbinafine at a dose of 3 to 6 mg/kg/day (compared at 1 and 4 weeks with typical griseofulvin treatment), appeared to be an optimal duration for patients with T. tonsurans tinea capitis. Gaughan and Aronoff (2004) determined that a 2 to 4 week course of terbinafine was as effective as a 6 to 8 week course of griseofulvin for treating trichophyton infections of the scalp. Although the cost of griseofulvin is approximately one-half that of terbinafine, a typically shorter course of terbinafine implies its cost effectiveness. Fluconazole dosed at 6 mg/kg/day, once daily for 2 to 6 weeks, is available as a suspension. Approved to treat systemic fungal infections in all age groups, it is a reasonable therapeutic alternative. Practitioners must keep in mind, however, that griseofulvin is the only antifungal medication the Food and Drug Administration approved for tinea capitis. Ketoconazole 2% and selenium sulfide 1% shampoos, used concurrently with oral antifungal therapy, also have been recommended as therapeutic adjuncts to reduce the spread of infection and allow children to return to school once therapy has been initiated (Chan & Friedlander, 2004). These shampoos should be used at least 3 times a week and remain on the scalp for 5 to 10 minutes. Chan and Friedlander (2004) also recommend that asymptomatic family members use the shampoo for several weeks to prevent infection.

Parental role. Parents play the most critical role here. First, they need education to understand why they must insist on preventive measures (having all family members use antifungal shampoos) or if necessary, insist on getting the entire family tested (and treated with antifungals if cultured positive for tinea capitis). Parents need to understand that sharing brushes, combs, hats, hair ties, headbands, or any other items in contact with the head (e.g., pillows or sheets) is to be strictly policed and avoided. In addition, they need to be taught the specific protocols for administering medication, particularly griseofulvin. Occasionally children may develop a fine pink pruritic, papular, or vesicular exanthem on the head, neck, and shoulders once griseofulvin is initiated. Parents need to know this is a hypersensitivity reaction to a fungal agent and not a drug reaction (Elewski & Krowchuk, 2001). True allergic urticaria and angioedema are rare (Elewski & Krowchuk, 2001). Finally, one other preventive measure may prove helpful. A multicenter study involving three national urban referral centers used a convenience sample of 66 children with clinical symptoms of tinea capitis. Although Sharma and colleagues (2001) failed to find an association of tinea capitis with hair care styling practices, a protective effect was found for the use of hair conditioners. They recommend larger studies be conducted to further analyze the use of conditioners as a method of preventing the spread of tinea capitis.

Encouraging Collaboration of Parents/Adult Caretakers and School Personnel

Parents. Although nurse practitioners’ knowledge of appearance, etiology, and choice of treatment are critical factors, parent education and compliance greatly contribute to decreasing the spread of infection among siblings, families, and contacts. Many factors are involved in parental and child health care education, but attendance and adherence to treatment are arguably the most basic necessities for effective treatment delivery (Nock & Ferriter, 2005). Obviously, compliance in small children is highly dependent on their parents (Niggemann, 2005). When parents believe that the disease itself puts their child at risk, the medication is safe, and the health care provider is trustworthy, they are more compliant with treatment. For example, Mann, Eliasson, Patel, and ZuWallack (1992) found that parental influence on child compliance in the acute phase of asthma was greater than that in maintenance therapy. Similarly, several of the skin disorders presented here have an acute phase followed by a lengthy maintenance period requiring compliance. Lack of compliance may result in treatment failure, antibiotic resistance, recurrent morbidity, missed school time, and consequently, loss of parental work and wages.

In addition, the infected child’s self-esteem may be negatively affected if a persistent unsightly appearance and infectious status around peers and others is not resolved as quickly as possible (Harrison & Sinclair, 2003). “Children with visible skin disease affecting their appearance are negatively impacted the most. They have the challenge of having to prove that they demand the same level of respect and social regard” (Hilton, 2004). This sometimes not-so-subtle form of intolerance may extend beyond the classroom to the child’s own home environment as well.

Because the skin is the most visible portion of the body, defects in its surface that alter its appearance are sometimes a source of distress to the child and a source of revulsion and rejection by others. Parents of other children may fear that their children will “catch” the disorder. Occasionally the affected child’s own family members will reduce their interaction with him or her, especially close physical contact, or otherwise demonstrate a distaste for the condition, which the child may interpret as rejection (Hockenberry, 2003).

With this in mind, health care providers should first carefully assess the extent of parents’ knowledge about the skin disorder. What gaps in understanding need to be filled in? What concerns, especially ones resulting in actions the child may perceive as rejection, need to be addressed? Next, treatment rationale and ramifications of noncompliance need to be firmly and factually presented. Finally, instructions for treatment need to be clarified, simplified, adjusted, written out, and/or interpreted (if English is not the native language) to ensure understanding. Andal (2006) suggests a diary be kept of any concerns that arise, a verbal commitment be made to comply with the treatment outlined, and there be a discussion of positive and negative consequences associated with compliance and noncompliance.

School personnel. Although parental understanding and compliance are critical, alone, they are often not enough to ensure treatment success. According to Mears, Charlebois, and Holl (2006), school- based clinics are becoming an integral part of the health care system for low-income children. Obstacles to medication adherence are lack of health insurance, poverty, transportation dilemmas, health literacy, confidentiality, language barriers, and working parents who are unable to keep medical appointments. Their study of 81 students over the age of 10, found that only 55.6% of the students filled their prescription, 75.6% self- administered their medication at the correct time, and 22% sometimes forgot to take their medication. Therefore, ideally, a team approach involving parents/caregivers, health care providers, school nurses/teachers, and pharmacists is needed to encourage and influence adherence to treatment. Each team member offers important contributions to the treatment regimen and outcome.

Thus, the first step toward a successful outcome is the health care provider’s initial accurate diagnosis of these common pediatric skin disorders. Then coordination of care involving a team approach will help ensure adherence to treatment and prevent risking further spread of the disease as well as further angst and embarrassment to the child.

References

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Andal, E.M. (2006). Compliance: Helping patients help themselves. Clinician Reviews, 116(3), 23-25.

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Archer, J.M., & Archer, D.F. (2002). Oral contraceptive efficacy and antibiotic interaction: A myth debunked. Journal of the American Academy of Dermatology, 46, 917-923.

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Harrison, S., & Sinclair, R. (2003). Optimal management of hair loss (alopecia) in children. American Journal of Clinical Dermatology, 4(11), 757-770.

Hilton, L. (2004). Psycho-social dysfunction: Psychosocial effects of skin disease impact on lives of the youngest patients. Dermatology Times, 25(3), 19-23.

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Mancianti, F., Nardoni, S., Corazza, M., D’Achille, P., & Ponticelli, C. (2003). Environmental detection of Microsporum canis arthrospores in the households of infected cats and dogs. Journal of Feline Medicine and Surgery, 5, 323-328.

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Debbie Popovich, MSN, ARNP, is Clinical Assistant Professor, University of Florida College of Nursing, Gainesville, FL.

Allison McAlhany, MSN, ARNP, is Clinical Assistant Professor, University of Florida College of Nursing, Gainesville, FL.

Note: This article is reprinted with permission from Pediatric Nursing, 33(4), 315-320.

Copyright Anthony J. Jannetti, Inc. Aug 2008

(c) 2008 Dermatology Nursing. Provided by ProQuest LLC. All rights Reserved.

Satellite Healthcare Announces 2008 Norman S. Coplon Extramural Grants

Satellite Healthcare, Inc., a leader in the field of kidney disease services and research, today announced the recipients of its 2008 Norman S. Coplon Extramural Grants. Recipients of these annual grants are young scientists at leading universities and medical centers in the United States and Canada who are pursuing innovative kidney disease research projects.

These grants, named for Dr. Norman S. Coplon, the founder of Satellite Healthcare, are directed at young researchers in the relatively early stages of their careers. “These grants can be seen as seed money for talented young scientists who are building their reputations doing basic and clinical research in kidney disease,” said Dr. John Moran, Senior Vice President of Clinical Affairs for Satellite Healthcare and WellBound. “We want to motivate and help the best and brightest of young researchers to devote their time and energy to studying kidney disease, which affects 26 million Americans with another 20 million at risk of developing the disease.”

“Funding for medical research in the US is at an all-time low, and young researchers are leaving at an alarming rate because the future is so discouraging,” said Dr. William Mitch, Gordon A. Cain, Professor of Medicine at Baylor College of Medicine and chair of the Satellite Research Scientific Advisory Board and grant selection committee. “Through these generous grants, Satellite is not only supporting innovation and new treatments but also is helping people remain in research, and that’s our future. You can’t overstate how important these grants are.”

The 2008 Norman S. Coplon Extramural Grant recipients are:

Gabriela Garcia, M.D. Baylor College of Medicine

“Arrest of Kidney Disease Progression by A2A Adenosine Receptor Activation”

Yoshi Hall, M.D. University of Washington

“Disparities in end-stage renal disease among Asians and Pacific Islanders”

Susanne Nicholas, M.D. David Geffen School of Medicine UCLA

“Investigating Prevention and Mechanisms of Type 1 Diabetic Nephropathy”

Alan Pao, M.D. Stanford University

“Gamma-Melanocyte Stimulating Hormone Signaling: Implications for Salt-Sensitive Hypertension and Chronic Kidney Disease”

Venkataraman Ramanathan, M.D. Baylor College of Medicine

“Biofilms in Hemodialysis Catheters”

Rajeev Rohatgi, M.D. Mount Sinai School of Medicine

“Mechanoregulation of Fibrosis-associated Protein Expression in Renal Tubular Epithelia”

Tarak Srivastava, M.D. University of Missouri, Kansas City

“Role of PGE2 in Podocyte Biology: Implications for Progression of Chronic Kidney Disease”

Mark Unruh, M.D. University of Pittsburgh School of Medicine

“Sleep in Children and Adolescents with Chronic Kidney Disease”

Grant proposals submitted to Satellite Research, a division of Satellite Healthcare, are reviewed and approved by the independent Satellite Scientific Advisory Board. While research topics for the grants are not restricted to any one clinical area, applicants must focus on topics that exhibit scientific merit and potential for clinical application. The Coplon Grants allow for a maximum of $50,000 per year for a maximum of three years for each recipient.

About the Coplon Grants

The Norman S. Coplon Extramural Grant Program is one of the nation’s largest private research endowments for research into chronic kidney diseases. Satellite Philanthropy awards these extramural grants to individuals and institutions engaged in promising kidney disease research in the United States and Canada. Approximately one-third of the awards are for bench (i.e., basic science) research, with the remaining two-thirds aimed at clinical or translational research that can be introduced into clinical practice today.

About Satellite Healthcare

Satellite Healthcare, Inc. is one of the nation’s first and largest providers of dialysis services and kidney disease care. With its affiliated services Satellite WellBound, Satellite Dialysis, and Satellite Research, Satellite Healthcare provides early patient wellness education, personalized clinical services and a complete range of dialysis therapy choices. This comprehensive offering allows Satellite Healthcare to advance the standard of chronic kidney disease care so patients can achieve a better life.

For more information: www.satellitehealth.com or call 650.404.3600

As More Couples Seek Treatment for Infertility, Missouri Baptist Increases Staff in Its Fertility Center

ST. LOUIS, Sept. 22 /PRNewswire/ — To meet the increasing number of women seeking treatment for infertility, The Fertility Center at Missouri Baptist Medical Center has recruited infertility specialist Todd David Deutch, M.D. to its staff.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080922/AQM185)

“Approximately one in every 10 couples in this country battles some form of infertility and the need for treatment has grown significantly,” said Dr. Anthony Pearlstone, medical director for the Fertility Center. The Fertility Center, formerly The Infertility Institute, has provided specialized medical care for infertility treatment, as well as early, recurrent pregnancy loss since 1998. “Dr. Deutch’s expertise will help us to care for the increasing number of couples seeking fertility treatment.”

Dr. Deutch is board-certified in OB/GYN and board-eligible in Reproductive Endocrinology and Infertility. He received his medical degree from Tulane University Medical School, completed his residency in OB/GYN at the University of Chicago, and completed a fellowship in Reproductive Endocrinology and Infertility at the Jones Institute for Reproductive Medicine, Eastern Virginia Medical School.

We chose to align our practice with Missouri Baptist Medical Center because we share a vision with the hospital for providing cutting-edge medical treatment in a setting that prizes personalized treatment and caring,” said Dr. Pearlstone. The Fertility Center often treats couples with difficult infertility problems, including those who have failed at other programs.

The Fertility Center features an extensively equipped, state-of-the-art IVF/ART laboratory where the most advanced procedures are performed, including intracytoplasmic sperm injection (ICSI), assisted hatching, blastocyst culture and pre-implantation genetic diagnosis (PGD). This IVF/ART lab is accredited by the College of American Pathologists.

Under the leadership of Dr. Pearlstone, The Fertility Center’s IVF/ART (in vitro fertilization/assisted reproductive technology) success rates have been among the best in the nation. In fact, the Center’s success enables it to offer a refund option for qualified patients who do not achieve pregnancy with IVF/ART (in vitro fertilization/assisted reproductive technology) treatment.

Dr. Pearlstone, is a nationally-renowned, board-certified specialist in infertility and reproductive endocrinology as well as obstetrics and gynecology. A graduate of Washington University Medical School, he completed his internship at Brigham and Women’s Hospital/Harvard Medical School in Boston, his residency at Barnes Hospital, and a fellowship in infertility and reproductive endocrinology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

Learn the common causes of infertility and what treatments options are available when Dr. Deutch presents “Conquering Infertility: Achieve Your Dream of Having a Baby” on Wednesday, Sept. 24, from 6:30 to 8 p.m. in the hospital’s auditorium, located at 3015 North Ballas Road, St. Louis, MO 63131. To register, call 314-996-5433, toll-free 1-800-392-0936 or visit http://www.missouribaptist.org/ and click on community programs/wellness events and classes.

Patients interested in setting up appointments should call 314-996-7900.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20080922/AQM185PRN Photo Desk, [email protected]

The Fertility Center at Missouri Baptist Medical Center

CONTACT: Mary T. Beck, +1-314-996-7575, Cell, +1-314-707-6944,[email protected], for The Fertility Center at Missouri Baptist Medical Center

Web site: http://www.missouribaptist.org/

New Siemon Whitepaper and Video Compare the Cost and Performance of Copper and Fiber Optic Cabling in the Data Center

WATERTOWN, Conn., Sept. 22 /PRNewswire/ — Siemon launches a new whitepaper by respected data center infrastructure expert Carrie Higbie. Entitled “Comparing Copper and Fiber Options in the Data Center,” this detailed whitepaper and accompanying video is available for download at: http://www.siemon.com/go/cvf

Based on the well-known fact that most data center designs encompass a mixture of both copper and fiber cabling infrastructure, this Siemon paper discusses the common options and configurations available to data center professionals. Higbie details the merits of each solution on the basis of initial and lifecycle costs, including such subjects as power consumption and system performance. These factors are combined with application-specific needs such as channel length and system latency to provide truly actionable advice on data center cabling choices.

Excerpt:

“Power consumption for 10 Gb/s switches is currently a major factor in the cost analysis of balanced twisted-pair vs. optical fiber cabling in the data center. With first generation 10GBASE-T chips operating at 10-17 Watts per port, lower power consumption is a goal and a challenge for 10GBASE-T PHY manufacturers. This is certainly something to watch as next generation 10Gb/s chips are expected to have much lower power demands — roughly one half of the first iterations. The same was seen in gigabit Ethernet, which from first generation chips to current technologies, saw a 94% decrease in power from 6 Watts per port to the 0.4 Watts per port figure we see today.”

To download an electronic copy of Siemon’s “Comparing Copper and Fiber Options in the Data Center,” including end-to end cost models for the most common Gigabit and 10Gb/s copper and fiber performance applications, visit: http://www.siemon.com/go/cvf

About the author:

Carrie Higbie has been involved in computing and networking for 25+ years in executive and consultant roles. She is Siemon’s Global Network Applications Manager supporting end-users and active electronics manufacturers. She publishes columns and speaks at industry events globally. Carrie is an expert on TechTarget’s SearchNetworking, SearchVoIP, and SearchDataCenters and authors columns for these and SearchCIO and SearchMobile forums and is on the board of advisors. She is on the BOD and former President of the BladeSystems Alliance. She participates in IEEE, the Ethernet Alliance and IDC Enterprise Expert Panels. She has one telecommunications patent and one pending.

About Siemon

Established in 1903, Siemon is an industry leader specializing in the manufacture and innovation of high quality, high-performance network cabling solutions. Headquartered in Connecticut, USA, with global offices, manufacturing and service partners throughout the world, Siemon offers the most comprehensive suite of copper (unshielded and shielded twisted-pair) category 5e, category 6 (Class E), category 6A (Class EA) and category 7/7A (Class F/FA), and multimode and singlemode optical fiber cabling systems available. With over 400 active patents specific to structured cabling, from patch cords to patch panels, Siemon Labs invests heavily in R&D and development of industry standards, underlining the company’s long-term commitment to its customers and the industry.

Siemon

CONTACT: Brian Duval of Siemon, +1-860-945-4380, [email protected]

Web site: http://www.siemon.com/http://www.siemon.com/go/cvf

Patients Take to Weekend Treatment at Cancer Hospital

By Madeleine Brindley

PATIENTS are receiving anti-cancer treatments at a special Saturday clinic in a Welsh hospital.

Velindre Cancer Centre’s weekend clinic has helped to boost capacity at the Cardiff hospital and reduce waiting times for patients.

Developed especially for women with breast cancer to receive Herceptin and other cancer drugs, the service could be extended to Sunday opening in the future or relocated closer to patients’ homes.

Cathy Barker, the integrated services manager and lead nurse at Velindre NHS Trust who pioneered the service, said: “Since the Saturday clinic on Rhosyn day unit opened in March 2007 we have been able to increase the number of treatments by 40%, enabling us to relieve capacity issues within the unit and of course providing a positive experience for our patients.”

She added that as well as being more convenient for patients themselves – it is easier to park at the hospital on Saturday and patients’ families are often able to accompany them – the Saturday clinic has also benefited the cancer centre itself. Staff have more time to talk to patients and to answer their questions because the clinic is not as busy as those run on weekdays.

The Saturday clinic has also helped to make a “positive difference” to the running of the Velindre’s inpatient unit in terms of resources and meeting staff and patients’ needs.

Ms Barker said many nurses were now asking to work on a Saturday as there are fewer interruptions and all the patients are pre- planned, so the treatments will have been made up for the day before the clinic begins.

She said: “We hope to be able to treat patients within three to four weeks of referral but that is now down to two weeks.”

The Saturday clinic was first opened in March 2007, seven months after the National Institute for Health and Clinical Excellence decided that Herceptin would be available on the NHS to thousands of women with early stage HER2-positive breast cancer.

Janet Langdon, a grandmother-of-eight, from Barry, was diagnosed with breast cancer in 2005.

The 65-year-old attended the Saturday clinic at Velindre regularly as she was put on a course of Herceptin and later involved in a clinical trial.

Mrs Langdon, a carer, is now taking a daily dose of the breast cancer drug Arimidex.

She said: “I was originally going to the hospital in the week but then they asked if I’d like to come in on a Saturday.

“It isn’t so busy on a Saturday and was, more or less, just the people who were having Herceptin – you didn’t have all the other people who were coming in for different treatments and blood transfusions.

“It was terribly stressful when the week-day clinics were busy because you would have to wait if another patient came in as an emergency.

“But the Saturday clinics are always on time and the time you spend in there has also come down.

“There would be people coming in to the Saturday clinic, having their treatment and going on to do their shopping, knowing that they were going to be seen almost immediately.

“There is a really nice atmosphere there and it is almost like a little club. You get to know the nurses more because there are fewer people – it’s much better.”

(c) 2008 Western Mail. Provided by ProQuest LLC. All rights Reserved.

How Just the Ten-of-Us 65 Years Ago Got Together to Raise Money – and Became the Cancer Research Charity Tenovus

By Madeleine Brindley

ON AUGUST 24, 1943, Cardiff-based haulage contractor Eddie Price was unloading heavy machinery when one of the lathes fell on him, pinning him to the ground.

He would spend the next three months recovering from his injuries in the old Cardiff Royal Infirmary.

In her history of Tenovus, Anna Marie Lovelock recalls that the charity also has its roots in a gesture of goodwill between Mr Price and founding chairman David Edwards, when Mr Price came to the latter’s rescue when he ran out of petrol earlier that year.

Speaking in 1993 Mr Price said: “This troubled Mr Edwards deeply and he said to his wife: ‘This chap did me a good turn. Now I’m going to do one for him.’ “He used all the influence he could command, and it was a great deal in Cardiff at the time, to bring the five finest specialists in the city to my bedside.

“It took three months to recover but I left on my feet rather than in a coffin. Starting from those meetings around my bed, he became the driving force.

“The rest of us ran small businesses but he knew how to bring powerful men together and how to raise money. Compared to him, we were little boys paddling along in his wake.”

When one of his friends brought him a portable radio that Mr Price was unable to use without disturbing other patients on the ward, his friends decided as a gesture of thanks to the hospital, they would equip all the beds with radio headsets.

As contributions started to grow for the appeal, they decided that they needed a name for this new group. As there were nine friends, and with Eddie they were ten, they called themselves Ten- of-us.

For the first few decades Tenovus concentrated on local community projects and played a leading role in the Burma, Sunshine and Danybryn Homes, Lovelock said. At the same time, the group developed close links with local hospitals and medical professionals.

The charity decided to focus its attention on medical research and care and in the 1960s Tenovus raised funds to set up a spin a bifida unit and the Tenovus Institute for Cancer Research.

Mr Edwards cut the first sod in 1964 on the site of Tenovus Institute for Cancer Research, in Cardiff for research into causes of cancer and to attempt to find a cure. Three years later Tenovus laboratories were set up at Velindre Radiotherapy Hospital, also in Cardiff.

In the intervening years, Tenovus has been at the forefront of cancer research – the Tenovus Centre for Cancer Research, in the Welsh School of Pharmacy, in Cardiff, is one of the most respected cancer research centres in the world with a history of successes.

Robert Nicholson, professor of cancer pharmacology and director of Tenovus cancer research centre completed a PhD with the support of Tenovus in 1972 and has worked for the charity since 1975.

He said: “As scientists, we have seen massive advances in cancer research over the last 30 years and we now have a much greater understanding of why cancer arises and the molecular alterations in cells that lead to cancer.

“With improvements in technology, this is set to continue and it makes our job one of the most exciting in the world.

“The majority of Tenovus’ previous research was focused on pre- clinical testing and clinical trials.

“Pre-clinical work is based in the laboratory and involves developing model systems for breast and prostate cancer. We take human cancer cells, grow them in our incubators and treat them with new anti-cancer drugs to monitor their efficacy.

“Although this process can take several years to complete, it is necessary before we can move to the clinical trial stage.”

An early success to come from the Tenovus Cancer Research Centre was the drug tamoxifen, which has become famous for its success in treating breast cancer.

The charity’s researchers were the first to show that the drug halted the growth of breast cancer cells. Tamoxifen has gone on to become established as the world’s most successful, and widely-used, breast cancer therapy – it is thought to have saved the lives of as many as 30% of all women diagnosed with the disease.

In the 1980s Tenovus trialled and tested Zoladex – the breast and prostate cancer drug, which is still in widespread use – followed in the 1990s by Iressa, which targets the cancer-causing gene the epidermal growth factor receptor.

Professor Nicholson said: “Personally, the highlight of the role I play in the centre is to see the drugs that we test in the laboratories being used to the benefit of the cancer patient.

“Looking forward, the future of Tenovus research will focus on understanding the mechanisms whereby cancer cells develop resistance to drugs such as tamoxifen – a phenomenon that limits their effectiveness. Importantly, initial success has shown that the targeting of such mechanisms in the laboratory is highly effective in killing the tumour cells and excitingly can dramatically delay – and in some cases even prevent – the development of resistance in the laboratory.

“If translated clinically, such approaches could significantly improve the outlook for many breast cancer patients.”

In addition to research, Tenovus has also concentrated on supporting people with cancer.

The Tenovus Cancer Information Centre was established at Velindre Hospital in 1983 and the Tenovus cancer helpline celebrates its 25th anniversary this year. Over the years the charity has funded social workers, counsellors, welfare rights advisers and specialist oncology nurses – the first organisation to do so.

As the cancer challenge in Wales changes – there are more cases of the disease but survival rates are improving with the advent of earlier detection and newer treatments. Tenovus will also adjust its focus, concentrating on bringing services closer to patients and actively contributing to the health awareness in local communities.

By the end of the year the charity will launch its mobile unit, which is designed to bring support, treatment and prevention messages into local communities, in partnership with the NHS.

It will be also opening a network of local support centres, to offer support, advice and information to people who have cancer, or who have experienced cancer and their families and loved ones.

Claudia McVie, chief executive of Tenovus, said: “Looking back over the last 65 years, it is incredibly rewarding to see the difference Tenovus has made to the lives of so many people affected by cancer.

“This not only includes the Tenovus-funded research which has saved the lives of millions of breast cancer patients, or the pioneering work on antibody therapies that has now lead to so many new cancer treatments being used in the clinic, but also the support, treatment and care from our social workers, counsellors and nurses which have helped many thousands of families through one of the most difficult journeys imaginable.

“As a charity that receives no government funding, these achievements have only been possible through the amazing fundraising efforts of the public and the incredible hard work and diligence of our staff and volunteers.

“One in three of us will be diagnosed with cancer in our lifetimes, and with an aging population, an ever increasing rate of cancer and an incidence of cancer in Wales that is already 22% higher than in England, this vital support and commitment is now more important than ever.

“The increasing incidence of cancer means that the needs of cancer patients in Wales are changing, and we are changing to meet those needs.

“Following extensive consultation with patients, clinicians and fellow cancer care providers, we have developed an innovative and unique strategy that will bring cancer treatment, support, and research into the community, closer to the people who are actually affected by this terrible disease.

“We will be achieving this through a network of local cancer support centres based in communities and a series of mobile units that will be able to deliver chemotherapy to patients closer to their home as well as all the support, care and counselling they and their families need.

“We will also be looking at ways of working in partnership with communities to develop together the health promotion messages and cancer prevention messages that could prevent as many as half of all people from developing cancer in the first instance.

“This holistic, community focussed approach to tackling cancer is truly innovative and will be unique to Wales, but big problems need bold solutions.”

Fundraising

Three dance teachers arranged a dancing show at the New Theatre, Cardiff in the 1960s. The Tenovus Dance Fantasia became an annual event raising thousands;

Legacy income and money in lieu of flowers has always been an important income for Tenovus. In 1975, a nine-year old girl died in the neurosurgery department of University Hospital of Wales and money in lieu of flowers was sent to Tenovus. The money included a significant gift from the girl’s grandfather and pounds 3 from the girl’s money-box;

Welsh schools have been instrumental in the fundraising effort. In 1978, three pupils from Rumney High School walked from Cardiff to Land’s End;

Until the mid-’80s, Junior Tenovus – a group of parents and children – raised large sums through flag days and barbecues;

In 1998, Catherine Zeta-Jones and Ioan Grufydd launched the Rough Guide to Cancer for Welsh schools and youth clubs. Following this, Ioan Grufydd fans in the US and Australia donated EUR3,000;

The Tenovus Lottery raised sums as high as pounds 2m;

There are 65 Tenovus charity shops located over Wales and the South of England – in the 1960s one of these sold a bag formerly owned by Queen Mary;

Tenovus launched the Purple Ribbon campaign raising awareness of male cancer in the ’90s;

Companies including Marks & Spencer, Barclays, HSBC and Buy As You View donate through the payroll giving scheme;

Future fundraising initiatives will include abseils in Cardiff, Swansea and Newport for Breast Cancer Awareness Month in October and a candlelight service on December 6, at Llandaff Cathedral with Treorchy Male Voice Choir and Howell’s School Choir;

But perhaps the biggest opportunity for Tenovus will be in 2010 when it becomes the official charity of the Ryder Cup, which will be held at the Celtic Manor, in Newport.

(c) 2008 Western Mail. Provided by ProQuest LLC. All rights Reserved.

PracticeOne Selected to Provide Automation Solutions to the Family Health and Help Center Community Health Center

PracticeOne is pleased to announce that the Family Health and Help Center (FHHC) of Rockville, IN has selected PracticeOne’s e-Medsys Solutions Suite to automate their Community Health Center.

Specifically, FHHC will utilize the e-Medsys EHR and the e-Medsys PM, both in ASP format.

Susie Waymire, FHHC Executive Director stated, “A number of different solutions were reviewed and after consideration and deliberation, selected e-Medsys from PracticeOne. Their solutions are easy to use, share a single database, and include many features for which other vendors were charging extra.”

Ms. Waymire went on to remark, “We also liked the option of going ASP or Client Server and decided that ASP for our CHC would be the preferred format. We will not have to deal with maintaining our own server, upgrading hardware, and worrying about backups. Plus, we like that our providers can securely access the system from any internet connection.”

“PracticeOne is extremely pleased to have been selected by FHHC as their automation solutions partner,” said Sheryl Miller, PracticeOne SVP of Sales and Business Development. “FHHC does really great work with their community, and we look forward to working with Ms. Waymire and the entire FHHC staff in helping to bring their Community Health Center to new levels of practice management and electronic health records efficiency.”

Contact PracticeOne at 877-eMedsys (363-3797), Extension 2922 or by email to [email protected] for more information on our e-Medsys Solutions Suite.

About PracticeOne, LLC (www.practiceone.com): The Company is a leading national provider of automation solutions, excellent for CHCs and medical practices of every size and specialty. These solutions include e-Medsys EHR, e-Medsys PM (now up to Version 20.1) and the Company’s own (not third party) e-Medsys Patient Access Portal. e-Medsys systems can be available as Client Server or ASP / SaaS (per the practice’s preference); a single database is shared for a truly unified solution. PracticeOne provides timely Implementation, excellent Training and ongoing Support (which always includes Updates).

About Family Health and Help Center: The FHHC was established in 1991 to provide affordable, accessible quality heath care to families/individuals of Parke County and surrounding areas that are uninsured, underinsured or low-income. Ms. Waymire can be reached by calling FHHC at 888-340-3442.

 Contact: Marc E. Klar VP Marketing 877-363-3797, Extension 2922 [email protected]

SOURCE: PracticeOne

Extensively Detailed Report Offers Clinical Guidelines for Managing Care in Neurology and Neurosurgery

Research and Markets (http://www.researchandmarkets.com/research/275bf0/neurology_and_neur) has announced the addition of the “Neurology and Neurosurgery: Clinical Guidelines for Managing Care 2nd Edition, 2008 Update” report to their offering.

Evidence-based clinical and review criteria guidelines for outpatient and inpatient tests and procedures with indications, medical necessity coverage criteria, authoritative references and resources. Alzheimer disease 55 page clinical guideline & ADHD 54 page clinical guideline – both with extensive references and resource materials.

This ‘single topic’ contains medical and surgical guidelines and benchmarks that may be useful for screening requests for payment authorization for care. Each must be reviewed by the medical policy committee of the health plan or contracted/delegated medical group, modified and then adapted as appropriate before implementation as review criteria. It is strongly recommended that all applicable documents that will be used to manage medical care in the organization be sent to affected providers for review and comment prior to implementation. This will always promote an understanding of the guideline or benchmark, avoid compliance issues, and frequently improve the document by additional input. Cost effective health care is quality driven (true quality, that is; not excessive care) and attention must always be focused on the issues that will result in optimal medical/surgical outcomes in a specific local medical environment.

 Key Topics Covered: Aneurysm, intracranial - Aneurysm, intracerebral, screening indications - Aneurysm embolization, intracranial Antibody testing for neurologic disease Autism and other pervasive developmental disorders - clinical guideline Back and Neck Disorders or Pain - refer to the Skeletal-Muscular section that follows CNS/Brain Tumors Cervical spine/spinal cord acute injuries Convectin-enhanced intraparenchymal delivery of drugs to the brain Electrical Stimulation Therapies in Neuromuscular Disorders - Deep brain/thalamic electrical stimulation for intractable tremors (Parkinson's, dystonias, other tremors) refer to the Parkinson's section that follows - Facial nerve paralysis (Bell's palsy) - Cerebral palsy - Spinal cord injury - Stroke and other CNS Disorders - Cranial electrical stimulation/electrosleep therapy Neurology/Neurosurgery Studies - refer to guidelines throughout this and Radiology chapters for additional tests and diagnostic procedures - Autonomic Nervous System Function Testing - Brain death - diagnosis - Electroencephalogram (EEG) - std., ambulatory, sleep-deprived, surgical, - Brain mapping (quantitative EEG) - Electrocorticography (EcoG) EMG studies - also refer to the following Neurofeedback guideline - Electromyelogram (EMG)/Nerve Conduction Velocity (NCV) - Surface EMG, Spinoscopy - Electromyography, Anal or Urethral External Sphincter - Epiduroscopy - Neuromuscular junction testing by repetitive stimulation - Neuropsychological testing - Sensory Nerve Testing - Perception Threshold/Sensory Nerve Conduction Threshold (SNCT) - Sensory/Somatosensory Evoked Potentials - Visual and Auditory Evoked Response Tests Guillain-Barre syndrome (GBS): Therapy Headaches, migraine, tension, other - Cervico-occipital and cluster headaches - related procedures - Cranial Electrical Stimulation - Dihydroergotamine (DHE); Histamine desensitization therapies - Neuroimaging Studies for Headaches -Refer to the Radiology section Multiple Sclerosis (MS) - Diagnosis and Therapy Multiple Sleep Latency Test (MSLT) NeuroControl Freehand System Neurofeedback Training Neuropsychological Testing (NPT) - refer to the preceding guideline in the Neurology Studies section Percutaneous Neurotomy for Chronic Cervical Pain Sensory stimulation for coma patients Spasticity - Neurosurgical procedures - Selective peripheral denervation (Bertrand procedure) for spastic torticollis - Neurosurgical management of spasticity Spinal tap/lumbar puncture (LP), diagnostic Stereotactic cingulotomy Stereotaxic Depth Electrode Implantation Sympathetic therapy for chronic pain management - refer to DME chapter for guideline Sympathectomy, Thoracoscopic Carpal Tunnel Syndrome (CTS) - Conservative therapy - Low Level Laser Therapy for the Treatment of Carpal Tunnel Syndrome (CTS) - Carpal Tunnel Release Transient Ischemic Attack (TIA) - Hospitalization indications Trigeminal Neuralgia - Radiofrequency Ablation, Other therapies Parkinson's disease - Deep brain/thalamic electrical stimulation for intractable tremors (Parkinson's, dystonias, other tremors) - Pallidotomy for the treatment of Parkinson's disease - Fetal tissue Cell (mesencephalic, adrenal-brain and fetal xenograft) transplantation for the treatment of Parkinson's disease - Thalamotomy for movement disorders Seizures/Epilepsy - diagnosis and management - Electroencephalographic biofeedback for intractable seizures - Surgical evaluation for intractable seizure disorders - Grid Monitoring - Vagus Nerve Stimulation for the treatment of refractory seizures, depression Diabetic Neuropathy - refer to the preceding neurological testing section - Peripheral neuropathy with loss of protective sensation (LOPS) - H-wave stimulation for diabetic peripheral neuropathy with LOPS - Surgical decompression for diabetic neuropathy Cognitive Rehabilitation (CR) Sensory or auditory Integration Therapy/Training Constraint-induced movement therapy (CIMT) Head Injury - assessment and management Hippotherapy/Therapeutic Horseback Riding/Equestrian Therapy Hypothermia following acute brain injury Induced Lesions of Nerve Tracts, Medicare NCD Intra-operative Electromyographic Monitoring of Cranial Nerves Intraoperative Neurophysiologic Monitoring Invasive Intracranial Pressure Monitoring Shunt, subcutaneous lumbar Stroke prevention - Angioplasty of intracerebral arteries Stroke units Thalamotomy for movement disorders Ulnar Nerve Transposition, Decompression or Release Vagus Nerve Stimulation for the treatment of depression, seizures Vestibular - refer to ENT chapter Videopupillography/Tropicamide Drop Test Alzheimer's Disease Ziconotide Intrathecal Infusion (Prialt(R)) for Severe Chronic Pain Neurology/Neurosurgery Referral Guideline Links Neurology/Neurosurgery Notes Back and Neck Pain - Evaluation and Procedures; Refer to Apollo's Medical Review Criteria for Managing Care, DME chapter for additional related guidelines - Low back pain - evaluation and management introduction ('acute', 'slow to recover') - Algorithm for 'slow to Recover' back pain evaluation - Anterior Spinal Surgery, Endoscopic/Minimally Invasive - Artificial/Prosthetic Intervertebral Discs/Disc replacement - Cervical Spine - refer to related guidelines throughout this section - Cervical pain, acute, without preceding trauma - guideline - Cervical nerve root entrapment - surgical indications - Cervical Laminoplasty - Spinal Instability, cervical - lateral screw fixation - Chymopapain Chemonucleolysis - Endoscopic/Minimally Invasive Anterior Spinal Surgery- refer to Anterior Spinal Surgery - Epidural injections - steroids, nerve blocks - refer to spinal stenosis and the Anesthesiology section: Nerve blocks - Epidural adhesions - neurolysis - Facet Denervation: Neurotomy, Rhizotomy, or Articular Rhizolysis - Facet Denervation: Percutaneous Radiofrequency - Implantable Infusion Pumps for Chronic Severe Back Pain - Intervertebral Discs/Disc replacement - refer to 'Artifical/prosthetic intervertebral discs' - Intradiscal Electrothermal Therapy (IDET) - Laminectomy - Laser assisted spinal endoscopy - Machines to treat low back pain - Magnets for the treatment of chronic low back pain - Microdiscectomy, Percutaneous Lumbar Discectomy, automated - Neuroreflexotherapy (NRT) - NucleoplastyTM - Percutaneous vertebroplasty/kyphoplasty - Postural Reconstruction Physiotherapy - Prolotherapy - Scoliosis - Therapies - Spinal fusion/arthrodesis - Spinal Instability, lumbo-sacral - Pedicle screw fixation - Spinal stenosis - Interspinous distraction or dynamic stabilization for spinal stenosis (X-stop or Dynesys) - Surface electrical muscle stimulation for juvenile scoliosis- refer to guideline in DME chapter - Trigger Point Injections - Vertebroplasty, kyphoplasty - refer to percutaneous Neuroradiology Guidelines Spine - diagnostic radiology - Refer to CT and MRI sections that follow and the Skeletal-muscular chapter related topics - Low back pain imaging studies - Myelography and Cisternography - Discography - Scoliosis in children - indications for radiography - Videofluoroscopy of the spine (Motion X-rays, Dynamic Spinal Visualization) - Epidurogram/Epiduroscopy - Cervical spine; Diagnostic radiology; post-trauma Skull x-rays- post-trauma Diagnostic Arteriography/Angiography/Venography - Indications - Cervicocerebral angiography MRI/CT Overview CT Overview - Whole body CT Scans - CT angiography (CTA) - Computerized Tomography (CT or CAT) including headaches, extracranial head, brain, and thoracic scans; High-resolution CT (HRCT)for Pulmonary Studies MRI Overview including Standing and Sitting MRIs - MRI - Brain - MRI - Orbit, Face, and Neck -MRI - Spine - Magnetic Resonance Angiography (MRA) including Venography Neurovascular Imaging (update - Magnetic Resonance Neurography/Peripheral Nerves (MRN) - Magnetic Resonance Spectroscopy (MRS)/Nuclear Magnetic Resonance (NMR) - Magnetic Source Imaging (MSI)/Magnetoencephalography (MEG) Neuroimaging Studies for Headaches, Other Resources: Neuroimaging Alzheimer's Disease 2007 - 55 page clinical guideline - contents list on page 2 of guideline ADHD 2007 - 53 page clinical guideline - contents list on page 2 of guideline Refere
nces & Resources for Clinical Review Guideline Topics - Autism, Asperger, PDD Neurology and Neurosurgical web site resources 

For more information visit http://www.researchandmarkets.com/research/275bf0/neurology_and_neur

MD Biosciences Showcases Its Products and Services at the 2008 APLAR Conference

MD Biosciences, a global biotechnology company focused in inflammations & neurology research will showcase its inflammations related pre-clinical services and research products at the 13th Congress of The Asia Pacific League of Associations for Rheumatology (APLAR) in Japan on September 23 – 27, 2008. APLAR focuses on providing state of the art care to patients with arthritis and other musculoskeletal diseases through continuing professional development of members, increasing the awareness and understanding about rheumatic diseases, patient advocacy and empowerment, and fostering research in the field of rheumatic diseases.

MD Biosciences, with roots in the sales of rheumatoid arthritis research reagents, will feature it’s capabilities in preclinical outsourcing services such as the Collagen-Induced Arthritis (CIA), Collagen Antibody-induced Arthritis (CAIA), Adjuvant Induced arthritis (AIA), Monoarthritic Pain, along with general inflammation assays and the Senerga(R) Mode of Action Platform. MD Biosciences offers customization of all protocols as well as end-point readouts such as biomarker analysis, histology, and gene expression analysis. MD Biosciences research products featured at the conference include collagen related reagents and assays, ArthritoMab(TM) antibody cocktail, ELISAs, Aggrecan antibodies and T-cell antibodies.

In addition to the product and service offerings within Arthritis, MD Biosciences also offers products and services within other therapeutic areas such as Multiple sclerosis, Respiratory, IBD, Type I Diabetes, Endotoxic shock, Contact Dermatitis, Inflammatory and Arthritic Pain, Gliosis, and Parkinson’s Disease.

Our Inflammations Discovery Service offers quick start dates and timely delivery of data, specialized scientists with experience using small molecules and biologicals, standard and specialized routes of administration, customized protocols and the development of novel models.

About MD Biosciences

MD Biosciences provides products and pre-clinical services for companies engaged in inflammations and neurology research. The company is headquartered in Switzerland and has specialized laboratories located in the United States, United Kingdom, and Israel. A panel of scientific experts provides companies’ in-depth expertise and technologies to tackle problems and provide flexible drug discovery solutions, enabling smarter results faster.

The information in this press release should be considered accurate only as of the date of the release. MD Biosciences has no intention of updating and specifically disclaims any duty to update the information in these press releases.