Immigrant Children Are Increasingly More Likely to Lack Health Coverage

PHILADELPHIA, Sept. 22 /PRNewswire-USNewswire/ — Contrary to public perceptions, foreign-born children are increasingly uninsured, rather than publicly insured, in the wake of immigration policy changes, according to a study by public health researchers at The Children’s Hospital of Philadelphia.

Despite a 1999 federal ruling that relieved immigrant families of a requirement to repay the U.S. government for Medicaid benefits, immigrant children did not increase their usage of publicly funded health insurance programs. The study authors said that these inequities in access to health care may hinder the ability of immigrant children to become productive future members of the American labor force.

Even after taking into account significant socioeconomic differences between U.S.-born and foreign-born children, the vast majority of immigrant children are much more likely to be uninsured, living in poverty, and have parents with less than a high school education, according to the study. The results, based on the analysis of data collected from 33,317 children for the 1997 to 2004 National Health Interview Survey, appear in the November 2008 issue of the American Journal of Public Health.

“The large number of uninsured foreign-born children raises concerns about their long- term health and functional outcomes because regular health care supervision is critical to achieve optimal growth and development,” said study author Susmita Pati, M.D., M.P.H., a pediatrician and child health services researcher at Children’s Hospital and a Senior Fellow at the Leonard Davis Institute of Health Economics. “The cost of providing preventive primary care to children is relatively small when compared to other health care costs.”

Some have argued that uninsured immigrants may strain the resources of publicly funded health care systems by using expensive emergency care or because their treatment has been delayed. The study looked at data over the seven-year period to determine if foreign-born children were increasingly reliant on public health insurance programs after the 1999 reversal of the so-called “public charge rule.”

The public charge rule of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 initially required families to repay the U.S. government for public health benefits, including Medicaid, previously received at no cost. In 1999, the government specified that Medicaid benefits would be exempted from the public charge rule.

According to the study results, low-income U.S.-born children were just as likely as foreign-born children to have public insurance coverage. After 2000, foreign-born children were 1.59 times more likely than U.S.-born children to be uninsured versus publicly insured. Therefore, children were less likely to participate in public insurance programs after reversal of the public charge rule. Less than one-third of foreign-born children were publicly insured compared to more than 40 percent of U.S. children during this time.

One of every five children in the U.S. is a member of an immigrant family, according to the 2000 U.S. census. Immigrant families are complex in that parents and children may each have different immigration status, and since children rely on their parents to obtain the necessary health benefits, that may have an impact on child health outcomes. Federal, state and local policies can promote or hinder insurance coverage for immigrants.

“Policies designed to promote the healthy growth of this highly underserved population merit serious consideration, given their potential to ensure the future socioeconomic well-being of an increasingly diverse American population,” Pati said.

Shooshan Danagoulian, formerly a research assistant at The Children’s Hospital of Philadelphia, contributed to the study.

About The Children’s Hospital of Philadelphia: The Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children’s Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.chop.edu/.

   Contact: Juliann Walsh   Media Relations Specialist   (267) 426-6054   [email protected]  

The Children’s Hospital of Philadelphia

CONTACT: Juliann Walsh of The Children’s Hospital of Philadelphia,+1-267-426-6054, [email protected]

Web Site: http://www.chop.edu/

AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (Bicalutamide) From the FDA

WILMINGTON, Del., Sept. 22 /PRNewswire-FirstCall/ — AstraZeneca today announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market CASODEX(R) (bicalutamide) for its licensed advanced prostate cancer indication until April 1, 2009. AstraZeneca has been working with the FDA in the investigation of the safety and effectiveness of CASODEX in a pediatric setting but will not be seeking an indication in this population.

CASODEX is currently approved in the US at a dose of 50 mg daily tablet for use in combination with a luteinizing hormone-releasing hormone analog (LHRH-A) for the treatment of advanced prostate cancer (metastatic Stage D2).

AstraZeneca has a well-established prostate cancer portfolio including hormonal treatments CASODEX, launched in 1995, and ZOLADEX(R) (goserelin acetate implant), launched in 1989. Three Phase III clinical research trials (ENTHUSE program) are currently underway to evaluate the safety and effectiveness of an investigational compound, ZD4054, in non-metastatic and metastatic hormone-resistant prostate cancer.

About Prostate Cancer

Over 186,000 men will be diagnosed with prostate cancer in the U.S. in 2008, making it the most frequently diagnosed cancer in men.(1) After lung cancer, prostate cancer is the second leading cause of cancer death in men, with an estimated 28,660 deaths in 2008.(2) One in six men will develop prostate cancer in his lifetime.

About CASODEX(R) (bicalutamide) Tablets

CASODEX at a dose of 50 mg daily is a prescription medication approved for use in combination with an injection of a luteinizing hormone-releasing hormone analog (LHRH-A) for treatment of advanced prostate cancer (metastatic Stage D2).

CASODEX at a dose of 150 mg daily is not approved for use alone or with other treatments. See full Prescribing Information under the section on “CLINICAL PHARMACOLOGY-Clinical Studies-Safety Data from Clinical Studies using CASODEX 150 mg” for additional important safety information regarding CASODEX 150 mg.

Important Safety Information about CASODEX

There have been reports of liver function problems during treatment with CASODEX. Therefore, your doctor will monitor your liver function with a blood test before you start treatment with CASODEX, at regular intervals during the first 4 months of treatment, and at regular times after that.

The most common side effects that occurred during treatment with CASODEX plus an injection of an LHRH-A were hot flashes (53%), pain (21% to 35%, including pelvic, back, and general), weakness (22%), and constipation (22%). Other side effects (reported in 12% to 18% of patients) were urination at night, blood in urine, diarrhea, swelling, shortness of breath, nausea, and infection.

For more information about CASODEX, including full Prescribing Information please visit http://www.prostateinfo.com/.

About ZOLADEX(R) (goserelin acetate implant)

ZOLADEX 3.6 mg depot and 10.8 mg depot are prescription medications approved for use in combination with flutamide (an antiandrogen) plus radiotherapy for locally advanced prostate cancer. Treatment with the combination should start 8 weeks prior to starting and continue during radiation therapy.

ZOLADEX 3.6 mg depot and 10.8 mg depot are also approved to use alone for patients with advanced prostate cancer. ZOLADEX may help reduce the size of the cancer and reduce symptoms (palliative treatment).

Important Safety Information about ZOLADEX

ZOLADEX, like other luteinizing hormone-releasing hormone analogs (LHRH-As), may cause an initial rise in testosterone. When used alone, there may be a temporary worsening of prostate cancer symptoms at the start of therapy.

Common side effects that occurred during treatment with ZOLADEX (goserelin acetate implant) plus flutamide and radiation therapy or ZOLADEX alone included hot flashes, decrease in sexual desire and/or ability to have erections, diarrhea, pain (general, pelvic, and bone), lower urinary tract symptoms, fatigue, nausea, breast growth, swelling, rash, upper respiratory infection, and sweating.

For more information about ZOLADEX, including full Prescribing Information for ZOLADEX 3.6 mg Depot and ZOLADEX 10.8 mg Depot visit http://www.prostateinfo.com/.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people’s lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information visit: http://www.astrazeneca-us.com/.

(1) Cancer Facts & Figures 2008. American Cancer Society publication. http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts_and_Figures_2008 .asp. Accessed July 8, 2008.

(2) Cancer Facts & Figures 2008. American Cancer Society publication. http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts_and_Figures_2008 .asp. Accessed July 8, 2008.

(Due to the length of these URLs, please copy and paste into your browser.)

AstraZeneca

CONTACT: Laurie Casaday of AstraZeneca LP, +1-302-885-2699,[email protected]

Web site: http://www.astrazeneca-us.com/http://www.prostateinfo.com/

Company News On-Call: http://www.prnewswire.com/comp/985887.html

Should Minors Be Tested For The Breast Cancer Gene?

More women than ever are being tested for the breast cancer gene these, which forces the question: should children be tested?

Testing for the breast cancer gene has doubled in size since 2005. Since most insurance policies cover testing, it has become more popular than ever.

Many medical experts tell patients to avoid testing before 25, saying not a lot can be done prior to that age. Many doctors fear that the knowledge will only hurt the patient.

On the other hand, in studies conducted by the AP, people who have BRCA gene mutations and their children oppose this idea. Jenna Stoller, a freshman at Cornell University, is one of these children.

“I’m the kind of person that, like my mom, am more comfortable knowing something about myself than not knowing,” said Stoller. She tested positive shortly after her 18th birthday. This was a five year wait for Jenna, as she wanted to be tested at 13. Her mother made her wait.

Ten years after BRCA testing started, researchers are still learning the consequences that a patient’s positive test results can have on family members. Another chief concern is whether or not it is ethical to test a minor.

“The rule is, do no harm – test only if you can offer something that will help,” said Mary-Claire King, the scientist who found the first breast cancer predisposition gene, BRCA-1.

“I feel very strongly that people should not test their children, but children should make their own decision,” said Jill Stoller, the mother the Cornell student, Jenna.

A current study printed in the American Journal of Medical Genetics looked at how sons and daughters between the ages 18 to 25 were affected by discovering that a parent had tested positive for the gene. Many were not affected negatively by the news, but a handful said they felt disturbed.

“I was shocked, scared. I wondered if I was going to get the gene and realized I could pass it to my (future) kids. I would feel like it was my fault if they got cancer,” said a survey participant.

Wanting to test children after discovering the gene’s presence is an understandable reaction. Tammy LeVasseur first wanted all three of her daughters tested after discovering she carried the gene.

After considering the ethical responsibilities, she encouraged her two eldest daughters in their 20’s to be tested, but not her youngest daughter.

“I want to wait until I’m in my 20s,” 17 year old Jessica LeVasseur said. “They wouldn’t do anything about it. There’s no reason to worry now. I’d rather just be able to finish my teenage years without worrying about that.”

On the Net:

Hospital Study Examines Near-Death Experiences

Doctors in the US and UK are expected to participate in a large study that will examine near-death experiences in cardiac arrest patients.

The study, due to take three years and coordinated by Southampton University, will look at 1,500 survivors to see if people with no heartbeat or brain activity can have “out of body” experiences.

It will include placing on shelves images that could only be seen from above.

Many people report seeing a tunnel or bright light, others recall looking down from the ceiling at medical staff.

The researchers have set up special shelving in resuscitation areas to test this. The shelves hold pictures – but they’re visible only from the ceiling.

If you can demonstrate that consciousness continues after the brain switches off, it allows for the possibility that the consciousness is a separate entity,” said Dr. Sam Parnia, who is heading the study.

“It is unlikely that we will find many cases where this happens, but we have to be open-minded.

“And if no one sees the pictures, it shows these experiences are illusions or false memories.

“This is a mystery that we can now subject to scientific study.”

Parnia works as an intensive care doctor, and felt from his daily duties that science had not properly explored the issue of near-death experiences.

“Contrary to popular perception, death is not a specific moment,” he said.

“It is a process that begins when the heart stops beating, the lungs stop working and the brain ceases functioning – a medical condition termed cardiac arrest.

“During a cardiac arrest, all three criteria of death are present. There then follows a period of time, which may last from a few seconds to an hour or more, in which emergency medical efforts may succeed in restarting the heart and reversing the dying process.

“What people experience during this period of cardiac arrest provides a unique window of understanding into what we are all likely to experience during the dying process.”

Parnia and medical colleagues will analyze the brain activity of 1,500 cardiac arrest survivors, and see whether they can recall the images in the pictures.

Addenbrookes in Cambridge, University Hospital in Birmingham and the Morriston in Swansea, as well as nine hospitals in the US are expected to participate in the study.

On the Net:

Vara Health Launches New Line of Ultra Premium-Quality, High-Efficacy Nutritional Supplements to Fight Stress, Increase Energy, and Balance Digestion

Vara Health, Inc., announced today the launch of its new ultra premium-quality supplement line to fight stress, fatigue, and nutritional imbalances for people with fast-paced, hard-working lifestyles.

“Vara recognized the need for a new kind of holistic, high-quality supplement line that active, well-informed customers can trust to make a real difference in their lives,” stated Samie Asplund, Co-founder and President of Vara Health. “As such, we use only premium ingredients with guaranteed high potency and manufacture locally for tight quality control. In addition, our formulas are based on the latest research and are specifically designed to counteract stress, poor nutrition, and the health risks associated with today’s demanding, over-scheduled lifestyles.”

Asplund has been a consultant and entrepreneur in the health and wellness field for over a decade. “There are many supplement choices out there, but not always a lot of quality control,” she said. “We wanted to offer something different, so we chose to focus on providing only the highest quality products. This commitment fosters trust in our safe and effective products because we don’t think people should take chances when it comes to their health.”

Vara Health offers a selection of nutritional supplements for overall wellness and preventive health including exclusive formulas for energy and nutritional balance, cardiovascular health, digestive health, bone & joint health, and anti-aging. All formulas undergo extensive research, testing, verification, and rigorous manufacturing process control. Only premium raw materials are used and the potency of active ingredients is strictly measured and maintained. In addition, whole food and organic ingredients are used whenever possible.

All Vara Health formulas are attractively gift-packaged with sustainable wrapping materials and delivered as “gifts of health.” They are available only through the company’s website at www.varahealth.com.

Vara Health is the leading choice in high-quality nutritional supplements for busy, active people who want to embody the joys of wellness and peak vitality. Fully researched and tested to exacting standards, Vara Health offers exceptional quality and effectiveness. Because you can tell a great supplement by the way you feel — and the way you live — every day. For more information, please visit www.varahealth.com.

SOURCE: Vara Health, Inc.

SAVI Device for Treatment of Breast Cancer Shows Excellent Cosmetic Results, Few Side Effects

A new study of breast cancer radiation treatment performed at 21st Century Oncology has found that the SAVI(TM) applicator delivered excellent cosmetic results with minimal side effects, for women who had not qualified for breast conservation therapy using a previously available balloon device.

Reporting on 12 recent cases, the 21st Century Oncology study found no incidence of potential side effects such as seroma (fluid collection), pigmentation change, fibrosis (scar tissue) or infection. Indicating the precision of the SAVI applicator, the maximum skin dose of radiation for patients never exceeded the prescribed amount. In 92% of the cases, the cosmetic result was rated “excellent.”

The research team was led by Constantine Mantz, M.D. of 21st Century Oncology, one of the first medical organizations in the nation to offer this new and improved approach in breast brachytherapy, a radiation treatment that is delivered from inside the breast.

The study will be presented as a scientific poster at the annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), to be held Sept. 21-25 in Boston.

Breast conservation therapy includes lumpectomy – the surgical removal of the cancerous tissue within the breast plus a small margin of normal tissue immediately surrounding the tumor – followed by radiation. SAVI is a single-entry, multi-catheter device that allows the physician to customize the radiation dose depending on the patient’s anatomy and precise configuration of the surgical site.

“Our study demonstrated that SAVI provides a well-tolerated therapy for patients who otherwise would not be able to safely undergo treatment with the previously available balloon device,” said Dr. Mantz. “SAVI offers the physician multiple catheters for radioactive source loading and therefore total control over radiation dose distribution.”

Explaining the advantages for both physicians and patients, Dr. Mantz said, “I can lightly load catheters near the skin or lung to limit exposure of these sensitive structures. Also, I can heavily load catheters deep within breast tissue, to increase the radiation dose to places where the patient is at risk for harboring microscopic disease. We are very pleased with our clinical outcomes to date with SAVI.”

Prior to doing the study, Dr. Mantz and his research team believed that the multi-catheter applicator’s design might offer a preferable alternative for patients whose tumor cavities were too close to the skin for treatment with the previously available balloon method. Patients whose tumor cavities are within 7 millimeters of the chest wall or skin surface are often disqualified for treatment with the balloon device because of a potentially severe lung or skin reaction to the radiation.

This study tested the hypothesis by using the SAVI device to treat 12 patients who were found to have less than 7 millimeters skin-to-cavity spacing. None of the patients suffered a serious skin reaction to the treatment.

The device requires very little spacing between the cavity and healthy tissue, versus other brachytherapy devices that require several millimeters. Accordingly, SAVI expands the number of women eligible for brachytherapy, compared to balloon devices.

The SAVI applicator is a recent advance in accelerated partial breast irradiation (APBI). This shortened course of high-dose radiation therapy is designed for early-stage breast cancer patients following lumpectomy surgery. Breast brachytherapy is a type of APBI in which radiation is delivered from within the breast. APBI reduces treatment time from six or seven weeks — which is generally required with conventional external beam, whole-breast irradiation — to just five days.

About 21st Century Oncology, Inc.

21st Century Oncology, Inc. is a leading developer and operator of radiation therapy centers. These centers, which are freestanding and hospital based, provide a full spectrum of radiation therapy services to cancer patients. In its more than 20 years of operation, the company has developed an operating model which enables the company’s centers to deliver high quality, cost effective patient care. Currently, the company operates more than 92 centers in 16 states, including Alabama, Arizona, California, Delaware, Florida, Kentucky, Maryland, Massachusetts, Michigan, New Jersey, New York, Nevada, North Carolina, Pennsylvania, Rhode Island and West Virginia. For more information, go to www.21stCenturyOncology.com.

Meru Networks and Drager to Provide Reliable Mobile Patient Monitoring

Meru Networks wireless LANs have been verified to reliably deliver life-critical information from Drager’s patient-worn monitors, following comprehensive interoperability tests the two companies recently conducted.

The tests ensure that hospitals and other healthcare facilities can use Drager’s Infinity OneNet architecture and Infinity M300 patient-worn monitors with Meru’s single-channel, virtual-cell wireless architecture with the assurance that the combined solution will deliver vital patient data to healthcare professionals in a consistent and timely manner and with a guaranteed quality of service (QoS).

The two companies have initiated additional testing efforts to verify interoperability of Meru WLANs with other Drager products, including the company’s Infinity Delta, Gamma and Vista series of bedside patient monitors.

“The critical nature of patient data requires that we go through rigorous verification of any products that will be used to communicate between medical systems,” said Lars Roth, product manager for networks at Drager. “We must be sure that a patient’s vital sign information reaches caregivers in near real-time – even while the patient is ambulatory. Meru’s virtual cell architecture and airtime fairness algorithms allow Drager monitors to roam seamlessly across large hospital campuses, while ensuring needed reliability and QoS levels.”

The Drager test suite verified that Meru’s Air Traffic Control algorithms enhanced traffic handling, wireless roaming, encryption and load testing. QoS tests with competing traffic were run to ensure that, in a shared Drager Infinity OneNet network which runs both patient monitoring and hospital applications, the data from the patient monitors will always be prioritized over less critical data.

“Drager has leveraged the IEEE 802.11 standards to create a visionary approach to merging WLAN-based telemetry with other commercial healthcare applications,” said Sarosh Vesuna, Meru’s vice president of business development. “The Drager-Meru solution will allow hospitals with Meru Wi-Fi infrastructure to seamlessly adopt Drager wireless monitoring, while hospitals with an investment in Drager equipment can deploy a single Meru wireless LAN for all their medical and commercial requirements.”

About Drager

Dragerwerk AG & Co. KGaA is one of the international leaders in the fields of medical and safety technology. Drager products protect, support and save human life. Founded in 1889, the Group achieved sales of 1,819.5 million Euros worldwide and an EBIT of 151.9 million Euro in 2007. Today, Drager employs around 10,000 people in more than 70 subsidiaries worldwide and has representation in around 190 countries. The Drager Medical subsidiary offers products, services and integrated system solutions which accompany the patient throughout the care process – Emergency Care, Perioperative Care, Critical Care, Perinatal Care and Home Mechanical Ventilation. For more information, visit www.draeger.com.

About Meru Networks

Meru Networks develops and markets wireless infrastructure solutions that enable the All-Wireless Enterprise. Its industry-leading innovations deliver pervasive, wireless service fidelity for business-critical applications to major Fortune 500 enterprises, universities, healthcare organizations and local, state and federal government agencies. Meru’s award-winning Air Traffic Control technology brings the benefits of the cellular world to the wireless LAN environment, and its WLAN System is the only solution on the market that delivers predictable bandwidth and over-the-air quality of service with the reliability, scalability and security necessary to deliver converged voice and data services over a single WLAN infrastructure. Founded in 2002, Meru is based in Sunnyvale, Calif. For more information, visit www.merunetworks.com or call (408) 215-5300.

Tengion Announces Expanded European Orphan Medicinal Product Designation for Neo-Bladder Augment

EAST NORRITON, Pa., Sept. 22 /PRNewswire/ — Tengion Inc., a clinical stage regenerative medicine company focused on the development of neo-organs and neo-tissues, today announced that the European Medicines Agency (EMEA) and the European Commission (EC) have formally designated the Tengion Neo-Bladder Augment(TM) as an Orphan Medicinal Product for the treatment of neurogenic bladder associated with spinal cord injury. This expands the Tengion Neo-Bladder Augment’s existing orphan designation. Tengion announced in April 2008 that its Neo-Bladder Augment was granted EMEA and EC orphan designation for the treatment of neurogenic bladder in spina bifida patients.

This Orphan Medicinal Product Designation qualifies Tengion and its Neo-Bladder Augment for EMEA regulatory incentives, including eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees. Orphan Product designation also enables the Neo-Bladder Augment to qualify for 10 years of European marketing exclusivity upon marketing approval.

Spinal cord injuries can cause neurogenic bladder, a condition that can lead to kidney failure and incontinence, even when patients receive optimal medical treatment. Although satisfactory methods of treatment for neurogenic bladder have been authorized by EMEA, Tengion’s Neo-Bladder Augment may provide significant clinical benefit to those spinal cord injury patients who suffer from neurogenic bladder and warrant surgical intervention for their condition.

“We are extremely pleased that EMEA and the European Commission have further recognized the Neo-Bladder Augment’s potential to significantly improve the treatment of neurogenic bladder, in this case in patients with spinal cord injury,” said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. “We look forward to continuing to work with the EMEA, as well as with the U.S. Food and Drug Administration, to move our neo-organs through the respective regulatory pathways.”

About Tengion

Tengion, a clinical stage regenerative medicine company, focuses on developing, manufacturing and commercializing human neo-organs and neo-tissues using our Autologous Organ Regeneration Platform(TM). Tengion uses biocompatible materials and a patient’s own (autologous) cells to create a functional neo-organ or neo-tissue that is designed to catalyze the body’s innate ability to regenerate. Tengion’s product candidates may ultimately address the most critical problems facing organ and tissue failure patients, enabling people to lead healthier lives without donor transplants or the side effects of related therapies.

Tengion Inc.

CONTACT: Gary Sender of Tengion Inc., +1-267-960-4802; or Keri Mattox ofPure Communications for Tengion Inc., +1-215-791-0105

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

Os-Cal(R) Encourages Women Across The Country To ‘Do The Bump’ To Get Hip About Hip Fracture

PITTSBURGH, Sept. 22 /PRNewswire/ — This fall, a familiar dance move will bring women across the country together in an effort to protect them against a leading, yet often overlooked, health risk associated with falls – hip fracture. At http://www.oscal.com/bumpitup, the “bump” – the iconic dance in which people bump hips to the beat of the music – comes to virtual life as an entertaining way for women to “bump up” their hip health awareness.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080922/NY34245)

With the arrival of fall, Os-Cal(R), the number one doctor- and pharmacist-recommended calcium supplement, invites women to visit http://www.oscal.com/bumpitup to “do the bump” to learn more about hip fracture and share information with other women they care about. Each woman who “bumps” hip health information to a friend will receive a downloadable $3 coupon for any Os-Cal product. Visitors to the site can also enter a sweepstakes for a chance to win a trip to Hollywood, where they just might “bump” into a favorite celebrity.

Boning Up on the Facts

Although hip fracture is a serious health issue that will affect one out of three women by the age of 90 and results in more than 300,000 hospitalizations annually, awareness and concern of the risks associated with it remains low, according to Donnica Moore, M.D., president of the Sapphire Women’s Health Group and nationally renowned women’s health expert.

“Having healthy hips is vitally important to anyone who wants to live a healthy, active life,” she says. “However, there is still room for most women to educate themselves on hip fracture and how to lower their risks.”

According to a recent survey commissioned by GlaxoSmithKline Consumer Healthcare among women aged 45 to 64, 80 percent of those polled said that they do not worry about hip fracture. Also, although 92 percent noted that hip fracture could lead to the loss of ability to walk properly or at all, many did not realize some other serious consequences associated with it. In fact, only about one out of three realized that death is also a possible risk, even though one out of four women over 50 who suffers a hip fracture dies within one year.

While most women may not realize the severity of hip fractures, most agree that their hips greatly affect their quality of life. Most say that having healthy hips enables them to be as active as possible, enjoy life each and every day and do things like travel without worrying how they will get around. However, while about three out of four women said they consider taking care of their hips an important part of their healthcare regimen, not enough are taking the proper steps to do so. For instance, while taking a calcium and vitamin D supplement like Os-Cal is one of the best ways to keep bones strong, about a third of women 45 to 64 said they do not currently take one. Of those that do take calcium supplements, only about one out of six is taking them properly, in twice daily doses. Experts recommend taking calcium and vitamin D supplements in divided doses throughout the day, as the body can absorb only so much calcium at one time.

Role of Calcium and Vitamin D

Adequate calcium intake is one of the best defenses against hip fracture. A person’s body must maintain a constant level of calcium in the blood to function, and when the body’s intake level is too low, it meets its needs by stealing calcium from bones, weakening them over time. And while many people assume they take in enough calcium, more than 75 percent of all Americans are not getting enough in their diet, a statistic that increases among older women. About 90 percent of women over 50 and 99 percent of women over 70 do not get an adequate amount.

As important to bone health as calcium is vitamin D. Getting enough vitamin D is not only essential for calcium absorption, but also plays an important role in keeping muscles active and strong; some studies have shown that getting enough vitamin D can also help prevent falls. And like calcium, many people do not get enough. More than 70 percent of women 51 to 70 and almost 90 percent of women over 70 are vitamin D deficient.

“Even when women try to get enough calcium and vitamin D through diet, it’s still usually not enough,” says Dr. Moore. “Women can make simple choices in order to take a more active role in managing their bone health, and taking a calcium supplement like Os-Cal is a great first step.”

In addition to “doing the bump,” women who visit http://www.oscal.com/bumpitup can access useful tools like a calcium calculator to estimate current daily calcium intake and a fracture risk calculator to assess their risk of breaking a bone. Visitors to the site can read valuable information and tips on hip fracture risks, ways to reduce the risks, the role of calcium and questions to ask their doctor about hip fracture.

For more information on Os-Cal and hip fracture, and for official sweepstakes rules, visit http://www.os-cal.com/bumpitup.

Survey Methodology

The Os-Cal Bone Health Consumer Survey was conducted by Insight Express, on behalf of GlaxoSmithKline Consumer Healthcare, within the United States between June 20 and June 23, 2008, among 355 U.S. women ages 45 to 64.

About Os-Cal(R)

Os-Cal(R) is the number one doctor- and pharmacist-recommended brand of calcium supplement and has been proven effective in more clinical studies than any other calcium supplement brand. Os-Cal was introduced in 1951 and was the only branded calcium supplement from the 1950s through the 1970s, earning a legendary reputation in bone metabolism scientific circles by 1980. Each of its varieties, including Os-Cal 500+D, Os-Cal 500+Extra D, Os-Cal 500+Extra D Chewable and Os-Cal Ultra, also contain vitamin D, which is essential for calcium absorption.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world’s largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R) and NicoDerm(R), as well as many medicine cabinet staples, alli(R), Aquafresh(R), Sensodyne(R) and TUMS(R), which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Photo: http://www.newscom.com/cgi-bin/prnh/20080922/NY34245http://photoarchive.ap.org/AP PhotoExpress Network: PRN8PRN Photo Desk, photodesk

Os-Cal

CONTACT: Laura Kelly, GolinHarris, +1-212-373-6005,[email protected]; or Deborah Bolding, GlaxoSmithKline ConsumerHealthcare, +1-412-200-3872, [email protected]

Web Site: http://www.oscal.com/bumpitup

Celebration For Life Hosts Auction, Picnic Fundraiser

The ninth annual Celebration for Life Inc. auction and picnic will be held from noon to 5 p.m. Saturday, Sept. 27, at the Lancaster Liederkranz pavilion, 722 S. Chiques Road, Landisville (off the Route 283 Salunga exit).

There will be a live and silent auction of fine artwork, handmade crafts, sports memorabilia, catered dinners, weekend getaways, gift baskets and more.

The guest of honor is Manny Lapp, founder of Lapp Electric.

Cost is $20 for anyone 13 and older; children 12 and under get in free.

Food and refreshments included with admission.

Proceeds benefit the American Cancer Society Lancaster Unit, Hospice of Lancaster County, and Camp Can-Do for children cancer survivors.

For more information, visit the Web site www.c4life.org.

(c) 2008 Intelligencer Journal. Provided by ProQuest LLC. All rights Reserved.

Cautious Contractors Warm to Lilly-Covance Deal

By Wall, J K

When Eli Lilly and Co. announced Aug. 6 that it would more than double the amount of research and development work it outsources to Covance Inc., Dr. Alfonso Alanis got nervous.

The CEO of contract researcher Anaclim LLC worried that more work for Covance would mean less work for local firms that provide drug development services to Lilly.

Executives at other local firms, who asked not to be named because of confidentiality agreements with Lilly, also have fretted that their substantial work for Lilly might find its way into Covance’s hands.

But Lilly has taken concrete steps to assuage those fears. On the day it announced the deal, about 30 Lilly employees spent the day phoning, e-mailing and writing letters to more than 250 companies worldwide that have contracts with Lilly Research Laboratories, the research-and-development arm of the Indianapolis-based drugmaker.

Alanis, whose Indianapolis company manages several clinical trials for Lilly and derives 40 percent of its revenue from Lilly, got a call that day from two Lilly employees.

“They told us that none of the work is going to be affected,” he said. “We are very happy and very reassured to hear that.”

The value of research work Covance does for Lilly will rise to about $160 million a year, up from $60 million now, according to officials at the New Jerseybased company. Covance performs testing in multiple countries. The company already employs 1,000 people in Indianapolis who work on large clinical trials for drugmakers.

Of the additional work going to Covance, a “very small amount” is work that Lilly already outsourced to contractors, said Andy Dahlem, vice president and chief operating officer of Lilly Research Laboratories. The rest is work Lilly was doing in-house.

Much of the work was done at Lilly’s laboratories in Greenfield, which Covance has agreed to acquire for $50 million. Covance will offer jobs to the 260 Lilly workers at the Greenfield Laboratories, who conducted safety tests and other early-stage research on experimental drug compounds.

Lilly also will outsource some of its clinical trial monitoring work to North Carolina-based Quintiles Transnational Corp. and some data management work to New Jersey-based i3 Research.

The deals with Covance, Quintiles and i3 were just the latest, Dahlem said, in Lilly’s attempt to transform itself from a solo performer in the world of drug development to the conductor of an orchestra of firms that play together to make new pharmaceuticals. Lilly hopes this transformation cuts 20 percent off its cost of developing a new drug, which averages nearly $1 billion.

“A thriving Lilly with innovation and partnerships has got to be good for business in central Indiana,” he said.

Most executives at central Indiana companies that provide drug development services agree. But some also said Lilly’s transition could be rough on small companies.

“It could on a long-term basis help to make this into a much bigger hub in the life science industry. But a small business deals on a short string all the time. You end up saying, ‘You know, I really ought to be cautious right now,'” said Joe Pesek, CEO of PreClinomics Inc., an 18-person Indianapolis company that provides animal-based testing for experimental drug compounds. He declined to name any of his firm’s clients.

Long-term payoff?

The long-term potential Pesek and others see is that Covance’s expanded operations would act as an anchor store in central Indiana’s shopping mall of drug development services.

Drug development can include a host of different work, ranging from testing drug compounds in animals, analyzing a compound’s chemical and biological traits, testing whether a drug is safe for humans, recruiting doctors and patients for human clinical trials, and analyzing the data from such trials.

Covance, which is known as a contract research organization, or CRO, has said it could double or triple the work force at the Greenfield Laboratories as it brings in work from other drug companies besides Lilly.

“It’s like having Nordstrom or Saks at the Fashion Mall,” said David Johnson, CEO of BioCrossroads Inc., an Indianapolis-based life sciences development organization. “It gives you this large, visible, anchor – like CRO here, which we think is going to bring in business for all the CROs here.”

BioCrossroads already has been working with biotech drug firms in San Diego to come to Indiana for drug development services. The group’s Linx initiative hired a part-time representative in southern California in May.

But Johnson and others also hope Indiana firms can capitalize on the growing trend of big pharmaceutical companies outsourcing more and more of their research and development work.

Industrywide trend

That trend has in the last two years led to more than 40,000 announced job cuts among major pharmaceutical companies, including Johnson & Johnson, based in New Jersey, and Pfizer Inc. and Bristol- Myers Squibb Co., both based in New York.

Meanwhile, greater outsourcing has been a boon to Covance’s business. Its revenue has surged at a 12-percent to 18-percent clip in each of the last three years. In that same period, its profit spiked at least 21 percent every year.

Other large contract research organizations have experienced similar growth.

Alisa Wright, CEO of BioConvergence LLC, a Bloomington firm that provides several drug development services, said Covance’s reputation as one of the biggest CROs will draw much more attention to companies like hers in Indiana that are virtually unknown outside the state.

“There are likely to be other life sciences companies that become aware of what Indiana has to offer,” she said.

Some companies even expect Covance to do more outsourcing as it ramps up its work in Greenfield.

That’s what Michael Evans, CEO of AIT Laboratories in Indianapolis, thinks. AIT has done work for Covance in the past, but is not currently.

“It also bodes well for us because Covance might farm out some work,” said Evans, whose firm’s revenue already is up 105 percent this year. “As this work gets farmed out to partners, it’s going to bode well for everybody.”

Shawn Comella has the same view. The CEO of Monarch LifeSciences in Indianapolis said he’s currently working on a three-way partnership with Lilly and Covance. Monarch already does a significant amount of protein analysis for Lilly, but Comella declined to disclose how much.

About Lilly’s decision to funnel more work to Covance, Comella said, “If anything, I see it strengthening the threelegged stool between us and Covance and Lilly.”

Covance isn’t committing to farm out work to central Indiana companies. But it does agree those companies can benefit from Covance’s growth.

In an e-mail, Covance spokeswoman Laurene Isip wrote, “Local businesses in Indiana will stand to benefit from our presence in Indiana, as we grow and expand our business.”

Copyright IBJ Corporation Aug 25, 2008

(c) 2008 Indianapolis Business Journal. Provided by ProQuest LLC. All rights Reserved.

Calypso Medical and The University of Pennsylvania Health System Announce Collaboration for Proton Therapy

Calypso Medical today announced that it has received a $1 million grant from The University of Pennsylvania Health System to develop a compatible version of the Calypso(R) 4D Localization System that would enable real-time tumor tracking during proton therapy for cancer treatment. This funding will go toward developing a modified version of the Calypso System, utilizing GPS for the Body(R) technology, to function with its current high degree of accuracy in a proton therapy environment.

Calypso Medical’s GPS for the Body(R) technology uses tiny electromagnetic transponders placed in or around the tumor to provide precise, continuous information on the location of the tumor during external beam radiation therapy. Any movement by the patient, including internal movement of the tumor, may cause the radiation to miss its intended target and hit adjacent healthy tissue. In contrast to other tumor targeting solutions, Calypso’s GPS for the Body(R) technology provides continuous tumor position information, objectively and without ionizing radiation, thereby optimizing the delivery of radiation to the tumor and minimizing misapplied radiation to normal tissue.

Proton therapy is an advanced form of external beam radiation whereby protons rather than photons are directed at cancerous tissue. Proton therapy in theory has a significant advantage: protons can be delivered to deposit all of their energy in a single location. Proton therapy is highly precise and able to deliver higher doses of radiation to the tumor, lower doses of radiation to healthy tissue and a lower whole body dose compared to conventional photon therapy. As a result, when used with continuous targeting technology, proton therapy may demonstrate superior tumor control with reduced post-treatment side effects for a wide range of cancers requiring radiation therapy.

According to James Metz, MD, clinical director, department of radiation oncology, at The University of Pennsylvania Health System, “Today, we use Calypso Medical’s GPS for the Body(R) technology to guide treatment and manage motion for patients undergoing conventional photon radiation therapy treatment for our prostate cancer patients. The proton project collaboration has the potential of incorporating pinpoint accuracy and real-time tumor tracking in the proton environment. There are a variety of cancers where the tumor target is moving continuously and accurate real-time tracking would enable a wider population of cancer patients to benefit from the combination of proton therapy with the Calypso System.”

Eric R. Meier, president and chief executive officer, Calypso Medical notes, “We are delighted that a leading academic center with the reputation of The University of Pennsylvania Health System has recognized the critical contribution Calypso Medical could bring to the field of proton therapy. In addition to improving the accuracy of treatment, the Calypso System has been shown to reduce the set-up time of patients prior to the initiation of conventional photon radiation delivery. This rapid set-up time may allow proton facilities to increase throughput in their already very busy facilities.”

To date, Calypso Medical’s GPS for the Body(R) technology has been installed in over 50 leading radiation oncology centers across the US, and more than 2,000 prostate cancer patients have been treated with the real-time target tracking guidance of the Calypso System.

About Calypso(R) Medical

Calypso(R) Medical Technologies, Inc. (“Calypso”) is a Seattle, WA-based privately held medical device company. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon(R) electromagnetic transponders) to continuously, accurately, and objectively pinpoint and track the location of tumors for improved accuracy and management of radiation therapy delivery. Calypso addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion management during treatment. In addition, the Calypso(R) 4D Localization System’s non-ionizing electromagnetic guidance has been found to improve workflow efficiency and treatment room utilization. The technology is designed for body-wide cancers commonly treated with radiation therapy, including prostate, breast, lung, head, neck and other radiation therapy target organs. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed.

Oakmont Family’s Medical Legacy is Cancer

By Craig Smith

Bob Fescemyer wears two rubber bracelets on his left wrist, the telltale signs of his family’s battles with cancer.

One is for his son, Michael, who is dying of prostate cancer. The other is for himself, a survivor of the same disease. Bob Fescemyer was diagnosed in April and had his prostate removed in August.

“Sometimes I’m so angry at this disease if I could get my hands on it, I would strangle it,” said Fescemyer, 66, a retired 37-year veteran of the Oakmont Police Department, who was elected mayor of the borough in 2005.

But the family’s battle with cancer goes beyond father and son.

His father, John, had prostate cancer. His mother, Helen, died of lung cancer. His brother, John, died at 43 of a massive brain tumor – – and Fescemyer’s wife, Judy, 66, was diagnosed in 1998 with multiple myeloma, cancer of plasma cells, the white blood cells present in bone marrow.

“Every single person on my dad’s side had cancer,” said Judy Fescemyer, whose mother, Florence Christman, died of breast cancer, and father, Bill Christman, suffered multiple ailments, including cancer when he died. Her sister, Karen Hubler, 58, is dying of cancer in California.

The family’s cancer rate is unusually high, said Dr. David Whitcomb, chief of the division of gastroenterology, hepatology and nutrition at the University of Pittsburgh Medical Center.

Researchers have begun to focus on the role genetics plays in the growth of cancer among families.

“This is an issue that’s being hotly debated right now … Cancer genetics is an area of greater and greater recognition,” he said.

“It sometimes takes a combination of two or three things randomly inherited to put an organ at risk,” Whitcomb said.

Bob and Judy Fescemyer were high school sweethearts who married 48 years ago. His wife’s diagnosis hit him hard. He had to work that day, so she heard the news from her doctor herself. She wasn’t prepared for what she heard, and gave the news to her husband at home.

“I’m thinking I’m going to lose my wife,” Bob Fescemyer said. “I wished I would have been there.”

Doctors gave Judy Fescemyer five years to live. “She’s going into her 10th,” her husband said with a smile.

Their battle can be almost overwhelming at times, he said.

Judy Fescemyer was hospitalized for 31 days in 1999 while she underwent chemotherapy, radiation treatments, blood transfusions and stem cell replacement. Her husband slept at the hospital during her stay and kept a journal of “what I took, when I took it.”

They went to visit Michael at his home in Hopewell, Va., last month. Fescemyer took his son fishing and they spent a lot of time talking.

“It got pretty intense,” he said. “My son is dying. It shouldn’t be this way. I should be going before my kids.”

Michael Fescemyer, 44, is a 20-year Army veteran who served in Panama, Haiti and Iraq. He first complained of pain during his 13- month tour of Iraq and was told it was probably bad food or dysentery, his father said. He was diagnosed in late 2007.

Prostate cancer is the most common nonskin cancer in America, affecting one in six men, according to the Mayo Clinic, a renowned medical clinic in Rochester, Minn. Prostate cancer represents 25 percent of the almost 750,000 cancer cases reported in men this year, the American Cancer Society said.

Laughter helps them get through the tough days, Judy Fescemyer said. Even though she has outlived her doctor’s prediction, they don’t make long-term plans.

“We haven’t turned that corner yet,” she said.

Bob Fescemyer serves on the committee for the Riverview Relay for Life, which has raised $685,000 over the past eight years for cancer research.

“Every year I wore a T-shirt that said ‘committee.’ This year, mine said ‘survivor,’ ” he said.

He urges men to get a prostate cancer checkup and be tested for the disease early and often.

“Everything hinges upon finding this disease early and treating it early,” he said.

(c) 2008 Tribune-Review/Pittsburgh Tribune-Review. Provided by ProQuest LLC. All rights Reserved.

Alzheimer’s Disease Can Be Treated, Says Doctor

PETALING JAYA: If you are above 65 years old and often forget what you had for breakfast, you and the family may laugh away the matter.

But when your forgetfulness worsens to a situation where you are holding the car keys and wondering what to do with them, it is no more a laughing matter.

You may be one of 50,000 Malaysians with Alzheimer’s Disease (AD).

This is, however, not a death sentence as AD is treatable.

Kuala Lumpur Hospital geriatrician Dr Lee Fatt Soon said the earlier the problem was detected, the better the chances of managing it.

He said those who contracted AD would not die of the disease but of other risk factors like diabetes or high-blood pressure.

“As you undergo degeneration of the brain, you can’t take care of yourself. Some people have problems swallowing, some people fall and hurt themselves badly,” he told a seminar in conjunction with World Alzheimer’s Day.

The seminar was organised by the Alzheimer’s Disease Foundation Malaysia (ADFM) and Novartis Corporation Malaysia.

Senior lecturer in Geriatric Medicine at the Universiti Malaya Medical Centre, Dr Chin Ai-Vryn, said AD was a progressive disease with patients living up to five to 12 years after diagnosis.

“When a patient or his family starts to worry about his memory loss, seek help immediately.”

Patients diagnosed early can still perform normal tasks and be reasonably independent.

“People who smoke, do not exercise, have a poor diet or high- blood pressure or diabetes are more prone to contracting AD in their later years,” he said.

ADFM chairman Datuk Dr Yim Khai Kee said World Alzheimer’s Day 2008, with the theme “No time to lose!”, was a platform to gain recognition and support for patients.

(c) 2008 New Straits Times. Provided by ProQuest LLC. All rights Reserved.

Oakland Mom Collects Baby Clothes for Women in Need

By Barbara Grady

By Barbara Grady

OAKLAND — When Lisa Klein gave birth to her first child five years ago, she couldn’t help but think of the contrasts between her experience and those of some other Oakland moms.

Then 34 years old and eager to be a mom, Klein was surrounded by a loving husband, family and friends who were ready to dote on her new child. They had showered her with gifts and hand-me-down baby clothes. Still, once the baby was born, Klein felt overwhelmed by responsibility.

“I thought about what this must be like for people without resources and for mothers without husbands or supportive families,” she said.

Klein turned those thoughts into action.

She has since supplied more than 1,000 new moms from Oakland, Berkeley, Hayward and New Orleans with blankets and baby clothes for their newborns.

Klein, with her own toddler and preschooler in tow, has collected 10,000 pounds of slightly used baby clothes — yes, 10,000 pounds — washed them, sorted them into boxes for individual moms to receive and donated the boxes to local hospitals and health clinics. At the hospitals, which include Highland Hospital, Alta Bates Summit Medical Center and Children’s Hospital of Oakland, social workers have given them out to mothers and babies in need. Meanwhile, nurses at Asian Health Services’ prenatal clinic have given Klein’s boxes to expectant moms.

“When you are a new mom, you’ve got so much going on: You’re learning how to take care of a new born baby, you (may have) postpartum depression and you’re physically a little weak and very tired. You don’t have time to go shopping,” Klein said. “The babies deserve to be warm and cozy and clean, no matter what’s going on in the mom’s life.”

Hospital officials say Klein’s donations are well-received — and urgently needed.

“Lots of our patients are in difficult financial situations,” said An Nguyen, medical social worker for Highland Hospital’s OBGYN unit. Highland, a part of the Alameda County Medical Center, does not turn any patient away. Many of the patients in labor and delivery are young, single moms with little or no income, Nguyen said.

“They are just so grateful when they get these boxes,” Nguyen said. “What Lisa provides is very comforting to them. It’s just so nice.”

She recalled one 19-year-old homeless woman who asked nurses if she could keep the hospital blanket for her newborn. When Nguyen instead presented her with a whole box of blankets and clothing, the young woman wept in gratitude.

“The amazing thing is the boxes are not just one layette and a T- shirt,” Nguyen said. “There are like 20 outfits in there and books and a toy. And each box has a blanket.”

At Asian Health Services, patient Sihaam Omar said her older children need things for school so there is little money left over for her 7-month-old baby. Her family of six lives on her husband’s part-time job at a gas station.

One day, a nurse gave her a box from Lisa Klein.

“I was very happy,” Omar said. “I never met Lisa but she’s good. She makes people happy.”

At Alta Bates Summit Medical Center, where 8,200 babies are born a year, social worker Misty Schultz said the boxes have come to the rescue many times.

“They appear magically in the closet and then are available to help people and make sure they are ready,” Schultz said. One place they’ve been crucial is the neo-natal intensive care unit, where most babies are born early and parents are sometimes caught unprepared.

“The moms’ faces light up” when they are given a box, Schultz said.

Klein collects donations from bins she sets up at Cool Tops Cuts for Kids, a children’s hair salon at 5697 Miles Ave. in Oakland and 3367 Mt. Diablo Blvd. in Lafayette.

She also collects donations from Child’s Play clothing consignment shop on 5858 College Ave. in Oakland, which donates what it doesn’t sell, and in Marin County, from Playdate Cafe at 101 San Anselmo Ave., San Anselmo.

About once a week, Klein drives a route of pick up stops, her two children tucked into car safety seats in the back and bags of donations piling up around them.

At home, she washes the clothes and blankets and sorts them into boxes so each box has an assortment of supplies a baby would need, and marks each box “for a girl” or “for a boy.” The empty boxes are donated by The Winemine winery in Oakland.

“I try to put in the box everything a baby would need in the first 12 months,” Klein said. So a box typically contains a blanket or two, or a layette set, onesies, hats, pajamas, T-shirts, booties, several little outfits in graduated sizes and usually a book or two and a toy.

Klein’s volunteer work — which takes up at least 10 hours a week — began when her first child had grown out of her baby clothing and Klein was wondering what to do with them. It was 2005, Hurricane Katrina had just hit New Orleans and Klein read a posting on the Internet from a church near the city. It was pleading with the outside world, via Craigslist, to help hundreds of hurricane victims camped out on its front lawn by sending supplies. It especially needed things for newborn babies.

“That’s when I realized that’s what I should do,” Klein said. She sent 100 pounds of clothes that she and her friends collected to the Louisiana church.

Two years ago, Klein’s son, Jack, was born and she again was prompted by emotions and abundance to help other moms.

“I realized I wanted to help moms in my own community,” Klein said. “I live in Oakland, and I see there are people here who could really use some help.”

So she started something much bigger, a baby clothes collection and delivery system that has, by now, become a registered nonprofit group with its own Web site “LovedTwice.org” and delivers 10,000 pounds of baby clothes a year.

She wants other moms to reach out to fellow moms with recycled baby clothes. Klein’s Web site, www.lovedtwice.org, includes step- by-step instructions on how to donate.

“My heart goes out to the new mothers that don’t have a strong family support system,” Klein said. “The boxes I package are truly for them.”Hometown Heroes, a partnership between Bay Area News Group- East Bay and Comcast, celebrates people in the Bay Area who make a difference in their communities. In addition to highlighting remarkable individuals, the Hometown Heroes feature aims to encourage volunteerism, raise visibility of nonprofits and key causes in the area and create a spirit of giving.

Read about a new Hometown Hero every other Monday and watch the program on Comcast On Demand at Channel One-Bay On Demand-Hometown Heroes.

Lisa Klein– AGE: 39– BORN: Royal Oak, Mich.– OCCUPATION: Collects and distributes 10,000 pounds of baby clothes a year as a volunteer.– FAMILY: Klein; her husband, Bill, and two children, 5- year-old Cali and 2-year-old Jack, live in Oakland.

To help

Donate slightly used baby clothes to “LovedTwice” by bringing them to: Cool Tops Cuts for Kids, 5697 Miles Avenue, Oakland; Cool Tops for Kids, 3367 Mt. Diablo Blvd., Lafayette; Playdate Caf , 101 San Anselmo Ave., San Anselmo. Please no car seats or large toys. Visit www.lovedtwice.org for more information.

Originally published by Barbara Grady, Oakland Tribune.

(c) 2008 Oakland Tribune. Provided by ProQuest LLC. All rights Reserved.

KLMU Helps Meet Demand for Nurses

THE establishment of the Faculty of Health Science at the Kuala Lumpur Metropolitan University College (KLMU) is to meet the international and domestic demand for highly trained professionals in the field of nursing, medical lab technology, occupational therapy and physiotherapy.

Recently, the faculty launched the popular and much sought-after Diploma in Nursing having already achieved its quota for the first intake.

According to the World Health Organisation (WHO), it is recommended that a nurse-to-patient ratio of 1:200, while the Malaysian nurse-ratio is 1:645, as reported in the Nursing and Midwifery Board in Malaysia’s website.

At least 130,000 qualified nurses are needed by 2020 to meet WHO’s nurse-to-patient ratio.

KLMU has risen to this challenge to produce qualified professionally trained nurses who are both caring and knowledgeable.

According to head of the School of Nursing, the diploma is designed to produce safe and caring nurse practitioners who are able to critically analyse and competently solve patient and health care problems that reflect evidence based practice in any healthcare setting. The programme aims to nurture students with the right balance of soft skills, critical thinking skills and nursing knowledge.

She adds that soft skills is a necessary element in nursing education as health care issues are personal and hence nurses need to be able to empathise, counsel, and advise patients in all aspects sensitively.

The intensive diploma programme is a three-year course and the curriculum covers three core sciences namely, the Health Sciences, Behavioural Science and Nursing Science.

Upon completion, graduates will be able to apply the scientific foundation of nursing to assess, plan, implement and evaluate nursing care with the necessary soft skills and critical thinking skills.

KLMU has recently invested about RM3 million into its Health Sciences Faculty state-of-the-art laboratories, including the nursing programme, fitted with hospital simulation wards, skills laboratory and a practical room.

Experiential learning is an essential part of nursing education and KLMU nurses perform their practicum at selected hospitals and clinics.

The increasing demand for quality and affordable education has also resulted in the provision of a RM200 million purpose-built campus strategically located in Wangsa Maju, Selangor.

Targeted for completion in 2010, the state-of-the-art campus is only about 15 minutes from the KL city centre.

For more information, call 03-2694 2300 or visit www.klmu.edu.my

(c) 2008 New Straits Times. Provided by ProQuest LLC. All rights Reserved.

A `Mat Salleh’ Offers Alternative Hope

NO one would have expected a Mat Salleh to be one of the first to market Tongkat Ali in Malaysia, but that’s what Benjamin Scott Drewe did.

More than 10 years ago, this Australian herbalist registered one of the first lines of Tongkat Ali products in Malaysia.

Drewe, who has lived in Malaysia for more than 20 years, says he’s been attracted to the study of herbs since his teenage years.

“Growing up in an organic farm, it was easy to find my passion at an early age,” says Drewe, the managing director of Asia Botanicals.

“I take pride in building people’s trust in herbs. Herbal remedies are based on scientific research.

“Things have changed since ‘Grandma’s days’. Today we use science and technology to show the mechanism of herbs.”

Living among the Orang Asli in jungles around Malaysia, and also among people of Sumatra, Drewe has seen the many benefits in leaves, roots and seeds.

“I’ve travelled all over Malaysia, trying to find the best herbal remedy for ailments and I’m still amazed at the many cures there are in the Malaysian rainforests.

“Unfortunately many people are looking for quick fixes to their medical problems and are not patient to try alternative treatment.”

What most people don’t realise, he says, is that quick fixes come with quick side effects.

“Erectile dysfunction (ED) should not be left untreated as it is a warning sign for more serious ailments.”

Drewe warns that if you find herbal pills that work in one hour, it’s sure to be an adulteration of chemicals.

“Genuine herbal pills don’t have chemical adulterants that cause other problems in the future.

“It has no long-term side effects when used with the guidance of a professional herbalist.

“But most prescription drugs cause other health problems like headaches and sinusitis.”

Drewe says not every herb is safe, as there are herbal poisons as well.

“I’m against using the word ‘natural’ as if natural means safe. The important thing to remember when using alternative treatment is to get a good product and use the recommended dosage.

“When treating ED with Tongkat Ali high concentration extract, the dosage is usually not more than three pills a day.

“But people usually forget to take enough.”

Drewe says when people take alternative medication as and when they choose, they don’t reap the full benefits.

It also doesn’t help, Drewe says, that there are many fake products in the market.

“Whenever there’s a product out, there are sure to be counterfeits. When it comes to sex, men will pay whatever it takes.”

(c) 2008 New Straits Times. Provided by ProQuest LLC. All rights Reserved.

Britney Back in the Picture

By GEORGE TYNDALE

LESS than a year ago Britney Spears was taken into psychiatric care under a mental health order.

This breakdown followed a series of bizarre events, including having her head shaved, which mostly ended with the 26 years-old singer being photographed in floods of tears. She also broke off communication with her family.

Now Britney, we are told, is a picture of health and all is back to normal.

To prove this point we have been shown a new set of pictures taken at a party for her two sons, Preston and Jayden, who happen to have their birthdays two days apart.

The snaps were taken as Britney sat on the kerbside outside her mother’s house in Beverley Hills.

Which means that this grown woman left her son’s birthday party and an important family reunion in order to pose for the paparazzi on a public street.

Ms Spears may be well again. But normal?

(c) 2008 Sunday Mercury; Birmingham (UK). Provided by ProQuest LLC. All rights Reserved.

Calypso(R) Medical Technologies Reports Advancements in Radiation Treatment for Cancer Patients

Calypso(R) Medical Technologies, Inc. today announced the launch of the Adaptive Workflow Efficiency release, developed to provide connectivity between the Calypso(R) 4D Localization System(TM) and Varian Medical Systems’ 4D integrated treatment console (4DITC). The Adaptive Workflow Efficiency release is a product upgrade for current customers and will be showcased by Calypso Medical at the ASTRO 50th Annual Meeting at the Boston Convention and Exhibition Center on September 21 – September 25, 2008.

Known as GPS for the Body(R) technology, the Calypso System utilizes implanted Beacon(R) transponders to setup and continuously track the position of targeted tissue during radiation treatment. When the tumor site moves outside of acceptable limits, the clinician can immediately adapt therapy to ensure treatment is delivered as prescribed to the cancerous tissue while avoiding adjacent healthy organs.

The Adaptive Workflow Efficiency release is compatible with 3D conformal radiation therapy, conventional intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy. A suite of online and offline motion management solutions allows clinicians to optimize treatment while maintaining fast and efficient patient throughput. Online motion management solutions include Data Input(TM), enabling electronic data transfer from treatment planning to the Calypso System and the new Adaptive Couch Repositioning(TM) option, enabling motion management from outside the treatment room, dramatically improving efficiency and expediting treatment time. Offline motion management solutions include Beam On(TM) and new Trend Reports(TM), providing easy-to-interpret motion trend reports allowing a quick assessment of tumor motion over multiple fractions. Tracking data provides input to the clinicians to optimize a patient’s treatment based on their individual motion profile.

“Calypso Medical is committed to continuously advancing radiation treatment options. The Calypso Medical GPS for the Body(R) technology combined with Varian Medical Systems’ 4DITC, allows clinicians to manage tumor motion adaptively, throughout the delivery of the radiation treatment to improve overall workflow and clinical results,” said Christopher Haig, vice-president of marketing and business development at Calypso Medical.

Efficient workflow is at the heart of the Calypso System design. The Calypso System is compatible and complementary with conventional linear accelerators, including Varian’s RapidArc(TM) radiotherapy technology. With the advent of real-time target tracking from the Calypso System, physicians have increased clinical confidence knowing the target and radiation beam are aligned throughout treatment delivery.

Karla Knott, senior director of marketing for Varian Medical Systems notes, “The Adaptive Workflow Efficiency product highlights new connectivity between Calypso Medical and Varian. We are committed to standardized connectivity allowing support of unique operational advantages for the radiation therapy clinicians with industry innovators, like Calypso Medical.”

Future advancements currently under development(*) utilizing the Calypso System with Varian Medical Systems delivery technology will also be demonstrated at ASTRO this year including real-time methods to manage motion and adjust treatments during beam delivery. We are very pleased to be an important part of this exciting future innovation,” notes Eric R. Meier, chief executive officer and president of Calypso Medical.

A demonstration of this real-time motion management technology may be viewed at the Varian Medical Systems booth #547 and at the Calypso Medical booth # 1418.

About Calypso(R) Medical

Calypso(R) Medical Technologies, Inc. (“Calypso”) is a Seattle, WA-based privately held medical device company. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon(R) electromagnetic transponders) to continuously, accurately, and objectively pinpoint and track the location of tumors for improved accuracy and management of radiation therapy delivery. Calypso addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion management during treatment. In addition, the Calypso(R) 4D Localization System’s non-ionizing electromagnetic guidance has been found to improve workflow efficiency and treatment room utilization. The technology is designed for body-wide cancers commonly treated with radiation therapy. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed.

(*) Works-in-progress, not available for sale in the U.S.

Half Million Women Die In Childbirth And Pregnancy

The United Nations Children’s Fund (UNICEF) reported Friday that 536,000 women die in pregnancy and childbirth every year, often due to lack of emergency obstetrical care.  

In its report entitled “Progress for Children: A Report Card on Maternal Mortality”, the agency wrote that lack of adequate funding and political will were largely responsible for the world’s maternal mortality number, which has remained relatively consistent despite modest gains in Asia.

According to the report, around 50 million births in the developing world, roughly 40 percent of births worldwide, are not attended by trained medical staff. During 2005, more than 99 percent of the maternal deaths worldwide occurred in developing countries, with half in sub-Saharan Africa.

“One of the critical bottlenecks has always been access to highly skilled health workers required to deliver emergency obstetrical care, particularly caesarian sections,” said Peter Salama, UNICEF’s chief of health, during a press briefing.

In Africa and Asia, hemorrhaging is the leading cause of maternal death, responsible for one in three deaths, the report said.   Other causes include Infections, complications of abortion, hypertensive disorders, obstructed labor or HIV/AIDS are other causes, most of which can be easily treated in emergency health facilities with properly trained personnel.  

“The lifetime risk of maternal death in the developing world as a whole is 1 in 76, compared with 1 in 8,000 in the industrialized world,” said UNICEF.

Niger is the highest risk place to give birth, where women face a lifetime risk of 1 in 7 dying during pregnancy or childbirth.  In Sierra Leone, their risk of death is 1 in 8.

However, some developing countries, such as Mozambique and Sri Lanka, have reduced maternal mortality rates through a combination of emergency obstetrical care, family planning, training skilled birth attendants and post-natal care, all of which are critical to reducing maternal mortality, the agency said.

Considering the current annual average reduction rate of less than one per cent, the world will fall short of the Millennium Development Goals goal of reducing maternal mortality rates by 75 percent between 1990 and 2015, to less than 150,000.

“The time is right. We now know exactly what to do for maternal mortality reduction to make this one of the next big issues in global health,” Salama told Reuters.

Initiatives to fight epidemics in HIV/AIDS, malaria and tuberculosis now have the necessary international attention and funding, he said.

“But maternal mortality and child mortality do not yet receive the attention that the scale of the problem deserves.”

Salama said an additional $10 billion a year would be required to combat both child and maternal mortality.

Last week the agency reported that during 2007 more than 9 million children died before their fifth birthday.  Although the number represents a slight decrease from 2006, widespread disparities remain between rich and poor nations, UNICEF said.

On the Net:

Widely Revered Medical Chief

By CREAN, Mike

Many health professionals remember Ross Fairgray with affection.

As Medical Superintendent of Christchurch Hospital, Fairgray “went the extra mile” to make staff feel valued. When junior staff arrived from overseas, he met them at the airport, brought them home for dinner, helped them settle into their flats, ensuring they had everything they needed.

His son, Dr Andrew Fairgray, says his father was considerate towards others and totally without pretension.

The former GP, obstetrician and anaesthetist who became an outstanding health administrator died in Christchurch recently. He was 79.

Fairgray was born and raised in Auckland. He attended Mount Albert Grammar School and Auckland University, before completing his medical studies at Otago University. He graduated in 1954 and became a resident medical officer at Tauranga Hospital in the Bay of Plenty.

He married Iris Brown and they settled in Tauranga, a place they both loved. They had four children.

Daughter Liz says her mother was an academic and noted sportswoman whose dedication to her husband made his career possible.

After two years at the Tauranga Hospital, Fairgray went into general practice in the town. He worked also in obstetrics and anaesthesia. His son says he was a popular family doctor and enjoyed the work. However, he had difficulty saying “no” to anyone and his workload became too much. “He wore himself out.”

He took a lesson from a fellow GP and close friend who died at 40 from overwork. He returned to Otago University in 1967 and completed a Diploma in Public Health, which qualified him for hospital administration.

The family then moved to Auckland, where Fairgray took the position of Deputy Medical Superintendent at Middlemore Hospital. He won the keenly sought post of Medical Superintendent at Christchurch Hospital in 1969 and the family made its last move.

Fairgray led the medical sector of public health in Canterbury for the next 20 years, until his retirement in 1989. These were decades of major change, with the rebuilding of Christchurch Hospital and the restructuring of administration, from the North Canterbury Hospital Board to the Canterbury Area Health Board, and with the rising influence of non-medical managers.

His titles changed with the restructuring. His responsibilities encompassed management of Christchurch Hospital, including medical officers’ appointments and duties and patient care services, and overseeing all Canterbury public hospitals.

Liz says her father addressed an acute shortage of house surgeons on his arrival in Christchurch by writing to every medical school in the Commonwealth, extolling the virtues of the city. Many new staff arrived in subsequent years.

Medical Staff Association chairwoman Ruth Spearing said in a eulogy that his personal kindness helped Canterbury retain staff and there was no further shortage.

He had a major role in developing “the most collegial group of hospitals in New Zealand”.

Pat Cotter, of the Medical History Trust, says Fairgray was “a very good doctor, a really nice guy and an outstanding manager”.

He always knew exactly how the hospitals were functioning because “he spoke to the cleaners”.

Liz says this reflected her father’s strong Christian beliefs and “Leftish” politics.

“He loathed injustice and inequality.” He was a strong proponent of women’s rights, she says.

He was a firm believer in a publicly provided health system. His inability to offer services he saw as “desirable” for patients, because of budget restrictions, frustrated him. He agonised over conflicting calls for funding.

Andrew says his father was a mentor to many. People frequently visited in the evenings to discuss work and non-work matters and seek his advice. He was astute and “no pushover” for anyone trying to put one across him.

“He was no socialite but he had an incredible number of loyal friends,” Andrew says.

Fairgray turned down a plum position in national health administration, in Wellington, because his family was happy in Christchurch. Liz says he was devoted to wife and family. Even when his kidney disease made him so weak he could barely stand, he travelled to watch his grandchildren play hockey.

Illness was cruel to a man who had been so active. He was a prominent cross-country runner in his youth and always a keen walker. He remained a member of a walking group until recent years. He enjoyed sailing and often crewed in yacht races around Banks Peninsula. He took up skiing at 50.

He loved his garden and for many years rose each day at 6am, working for two hours among his 200 rosebushes, then riding his bike from home, in Fendalton, to the hospital. —Mike Crean

.

Ross Alexander Fairgray, born Auckland, December 14, 1928; died Christchurch, September 3, 2008. Survived by wife Iris, daughters Susan, Elizabeth and Helen, son Andrew, and eight grandchildren.

——————–

(c) 2008 Press, The; Christchurch, New Zealand. Provided by ProQuest LLC. All rights Reserved.

New Glass Crusher to Be Shown

DARE COUNTY | Dare County will unveil and demonstrate its new glass crusher at 11:30 a.m. Wednesday at the Public Works Facility at 1018 Driftwood Drive in Manteo.

The glass crusher eliminates the costs of transporting bottles to re cycling companies and will save the county about $30,000 a year. The crushed glass will be available free to Dare County residents to use for paths and gardens.

The public is invited to attend the event and a luncheon, followed by a tour of the facility. Reservations are required for lunch. Call (252) 475-5903 to a reserve a space.

Camden County

Church offers women’s study

The Church of the Redeemer will be holding the Christian women’s study “Anointed, Transformed, Redeemed: A Study of David” in seven sessions. The group will begin at 7 p.m. Sept. 30.

DVDs featuring Priscilla Shirer, Beth Moore and Kay Arthur will be used in the interactive discussion. Study materials are $12.95.

For more information, call (252) 337-7177 or (252) 337-7178.

Currituck County

Story times for kids offered

The Currituck County library will hold story time for ages 3 to 5 from 10 to 11 a.m. Tuesdays through Dec. 16.

Toddler Time will be offered for those 18 months to 2 years old from 10 to 11 a.m. Thursdays through Dec. 18.

For more information, call (252) 453-8345.

Womanless pageant is benefit

The Currituck County Law Enforcement Association will be holding its Womanless Beauty Pageant at 7 p.m. Oct. 25 at Currituck County Middle School.

The event is a fund raiser for a program to take children Christmas shopping and give them a pizza party.

The event will feature contestants from the Currituck County Sheriff’s Office and law enforcement association members.

Donations – monetary or gift items – are being accepted for this event . Business donations will be acknowledged in the event’s program and on the Web site.

Tickets are $7; children younger than 12 are free with non perishable items.

For more information or ticket sales, call (252) 453-8204 or visit www.cclea.net.

Wine festival sets season finale

It’s the last of the season for the Whalehead Club Wine Festival.

The finale will be held from 3 to 7 p.m. Wednesday on the North Lawn at Currituck Heritage Park.

A $20 admission includes sampling of wines, a souvenir glass and a complimentary tour of The Whalehead Club.

Music will be provided by the Mike Sadler Band. Concessions will be available.

Parking is free.

Pets on leashes are welcome.

Dare County

Disaster planning workshop is Friday

The Outer Banks History Center will host a workshop, “Disaster Planning for Heritage Collections,” from 9 a.m. to 4:30 p.m. Friday at 108 Budleigh St. in Manteo.

The program will provide essential training for personnel with disaster preparedness and recovery duties.

The cost is $15 and includes lunch, refreshments and all course materials.

Call (252) 473-2655 to make a reservation.

FUNDS will help fight child obesity

The North Carolina Division of Public Health has awarded $380,000 to the Dare County Department of Public Health to fight childhood obesity.

Dare County and four other North Carolina health departments were chosen from 29 applicants.

The money will be used for proven strategies to prevent childhood obesity.

Pasquotank County

Extension to hold pesticide classes

“Pesticide Applicators: Safety-Minded and Informed” will be held from 8 a.m. to 12:15 p.m. Friday at the Pasquotank County Center of North Carolina Cooperative Extension.

The classes will provide 2.5 hours in all categories.

Call (252) 338-3954 to reserve a seat.

Programs available at YMCA

The Albemarle Family YMCA is offering programs for children and teens.

Afterschool Gym N Swim for children 5 to 12: Registration ends Tuesday. Cost is $40 for members, $50 for non members. Session starts Thursday for six weeks on Thursdays from 3 to 5:30 p.m.

Music and Movement Class for ages 2 to 5: Registration ends Wednesday. Cost is $20 for members, $35 for non members. The session is Oct. 1 to 22 on Wednesdays from 11:30 a.m. to 12:15 p.m.

Albemarle Family YMCA Teen Night for ages 13 to 17: Tuesdays from 5 to 7 p.m. Members are admitted free, non members must pay $2.

For more information, call (252) 334-9622.

Perquimans County

Benefit gala tickets on sale

The Perquimans County Restoration Association will hold its fourth Biennial Preservation Gala on Oct. 25 at Albemarle Plantation.

Cocktails will be served from 6 to 7 p.m. with dinner at 7 p.m.

An auction and dancing will be held from 8 to 10 p.m.

Tickets are $60 per person and may be purchased at Newbold-White House or by calling (252) 426-7567.

The gala will benefit the Periauger, the Newbold-White House, the vineyard and the colonial kitchen garden.

regional

Volunteers needed to deliver meals

The Albemarle Commission Senior Nutrition Program needs volunteers to deliver meals to homebound seniors.

If you can donate at least one hour a month, call Audrey Holland, (252) 426-7093, ext. 230.

meetings + events

CAMDEN COUNTY

Commission meeting 8 a.m. Wednesday, Albemarle Economic Development Commission, Camden County Senior Center.

DARE COUNTY

Authority meeting Dare County Airport Authority, 7 p.m. Wednesday, Dare County a irport conference room.

Council meeting Southern Shores Town Council, 8 a.m. Tuesday, Pitts Center.

Fisheries meeting North Carolina Division of Marine Fisheries, 7 p.m. Tuesday, Roanoke Island Festival Park.

Joint special meeting Manteo Board of Commissioners and the Cemetery Board, 9 a.m. Tuesday, Manteo Town Hall.

Luncheon meeting Retired Educators of Dare County, 11:30 a.m. Thursday, Basnight’s Lone Cedar Cafe.

Public hearing Kill Devil Hills Board of Commissioners, 7 p.m. Wednesday, Administration Building.

Scout monthly meeting and new member sign-up Cub Scout Pack 117 of Kitty Hawk, 6:30 p.m. Tuesday, Kitty Hawk United Methodist Church.

Blood drive noon to 6 p.m. Wednesday, Mount Olivet United Methodist Church, Manteo.

Blood drive 10 a.m. to 3 p.m. Thursday, College of The Albemarle, Technology Building lobby.

PASQUOTANK COUNTY

Blood drives 10 a.m. to 3 p.m. Tuesday, Roanoke Bible College, Presley Hall; noon to 6 p.m. Tuesday, Elizabeth City State University, New Student Center.

Development authority 9 a.m. Thursday, Elizabeth City-Pasquotank County Tourism Development Authority, Elizabeth City Area Convention & Visitors Bureau.

Beverlie Gregory, (252) 441-1620,

[email protected]

Karen Santos, (252) 338-2590,

[email protected]

(c) 2008 Virginian – Pilot. Provided by ProQuest LLC. All rights Reserved.

Bringing Oceans to a Boil

By Festa, David

“. . . Ocean surface temperatures worldwide have risen on average 0.9[degrees]F, and ocean waters in many tropical regions have risen by almost 2[degrees] over the past century. This is 30 times the amount of heat that has been added to the atmosphere. . . .” MARINE BIOLOGIST Chris Rader recalls childhood summers when his father, Environmental Defense scientist Doug Rader, would take him diving in the Virgin Islands: “Schools of butterfly fish and Queen angelfish would swim by,” remembers Rader. “I learned to identify hundreds of tropical reef fish.”

Later, as a student at the University of North Carolina, the younger Rader was snorkeling off the Tar Heel coast to study temperate-water fish. Much to his surprise, he saw some of the same tropical fish he had seen in the Caribbean. ‘This was not what I was expecting at all-warm-water fish so far north,” he relates. Yet, the elder Rader confirms that tropical fish showing up’ in temperate waters no longer is a rarity. Ocean specialists have spotted larvae of butterfly fish, angelfish, and other tropical sea life floating in coastal waters as tar north as Woods Hole, Mass. This evidence points to fish shifting their ranges in response to wanning waters.

Observations show that the oceans have been heating up since 1975. Ocean surface temperatures worldwide have risen on average 0.9[degrees]F, and ocean waters in many tropical regions have risen by almost 2[degrees] over the past century. This is 30 times the amount of heat that has been added to the atmosphere, a significant number, even though the ocean has a lot more mass than the atmosphere. Moreover, the incidence of coral bleaching has increased worldwide since 1979, and scientists now generally link these mass events to global warming. The largest bout of coral bleaching ever (1997-98) occurred during the wannest-at least up until that time- 12-month period on record, and in nearly every region of the world. It was a wake-up call that global warming is not just a distant threat.

Scientists have known for a long time that the ocean plays a huge role in climate. Covering 70% of the globe, it stores 1,000 times more heat than the atmosphere, but often overlooked in the public debate on climate change is the ocean’s synergistic role-how it responds to the growing amount of heat-trapping gases in the atmosphere.

“Even five years ago, most people had no inkling of the extent to which global warming was affecting the oceans but, slowly, over the years a consensus has been building,” asserts Environmental Defense marine ecologist Rod Fujita. “Today, we are witnessing impacts that we largely attribute to warming-like the bleaching of corals, changing fish habitat. We’ve gone from denial to talking about how to manage the impacts and reduce the threat of climate change.”

A tidal wave of studies has swept through the scientific community, making headlines and setting off alarm bells that global warming is happening and its impacts are playing out in the ocean right now. One groundbreaking study about the relationship between oceans and the climate, published in Science, “goes a long way in laying to rest the arguments that atmospheric warming is caused by anything other than man-made greenhouse gases accumulating in the atmosphere,” maintains Bill Chameides, chief scientist at Environmental Defense. “This study is a critical piece of the global warming ‘jigsaw puzzle’-one of the pieces that enables us to see the overall picture more clearly.”

In anotner headlining study pointing to the rise in temperatures in the Earth’s oceans, Scripps Institution of Oceanography scientist Tim Barnett declares, “This is perhaps the most compelling evidence yet that global warming is happening right now and it shows that we can successfully simulate its past and likely future evolution.” The findings project water shortages in the western U.S., western China, and the Andes Mountains due to changing rainfall patterns and less snowpack. Two other studies show that, even if we were to stabilize greenhouse gases at 2000 levels, the Earth’s temperature and sea levels would continue to rise over the next 100 years.

“The ship is already in motion, and it will take immediate action to turn it away from the danger ahead,” sums up Environmental Defense climate scientist James Wang.

Since humans began burning fossil fuels like coal and gas for power, huge amounts of carbon dioxide and other heat-trapping gases have been released. From the beginning of the Industrial Revolution, the concentration of these greenhouse gases in the atmosphere has soared to levels higher than at any time in the last 420,000 years, warming the Earth on average by 1[degrees] over the last century.

Oceans and forests naturally absorb COz, and sometimes are referred to as “carbon sinks.” Seawater absorbs heat as well-it can store four times more heat per unit mass than air. In modern times, human activities have pumped CO2 into the atmosphere at a dramatic rate. The oceans have absorbed huge amounts of carbon dioxide and heat in the last 40 years, but not enough to keep these two elements from building up in the atmosphere.

Fujita points out that, because of the huge amount of heat soaked up by water, “The oceans are saving us from faster climate change- in essence, they are a big flywheel that delays rapid overheating of the Earth, putting a brake on the climate system. That’s the good news. The bad news is that the oceans only slow the atmospheric warming down. Once the oceans come to equilibrium with a greenhouse- gas warmed Earth, the excess heat will remain in the atmosphere and things will get much hotter.”

Oceans take up the slack

In effect, the oceans are taking up the slack for the atmosphere and delaying the full impacts of global warming, but where and how the oceans release this accumulated heat is uncertain at this point. What scientists do know is that, even if we cut our emissions of heat-trapping gases today, it would take centuries for gases now in the air to fall to more historically balanced levels-and it appears that changes are afoot in global ocean dynamics which could have profound ecological impacts. Significant changes loom for seabird and fish communities, ocean circulation patterns, and basic processes of ocean chemistry. Without emissions cuts, the effects will be even worse. “The natural vagaries of climate plus greenhouse effects add up to substantial changes we will need to deal with-and plan for,” contends Doug Rader.

Scientists cannot predict exactly how climate change will affect the ocean. “The impacts of global warming are likely to vary tremendously in different regions, due to the complexities of ocean circulation, chemistry, and biology. Increased temperatures, altered wind patterns, and increased carbon dioxide concentrations will interact in surprising ways, no doubt,” Fujita explains in his book, Heal the Ocean.

The oceans’ global system of currents is propelled by the force of cold, salty (and denser) waters sinking in the North Atlantic. This great volume of water falling downward, sort of a giant underwater waterfall, pulls water at the surface of the Atlantic Ocean north and creates a current that flows along the bottom of the seas. This movement is called the ocean conveyor-and what powers all that falling water is cold temperatures in the polar region and salinity.

Changes are under way in the mix of the ocean’s salt and freshwater that dramatically could affect this system of currents. The mix of salty and fresher water is determined by rainfall and evaporation patterns (or hydrological cycle). Changes in patterns of precipitation and evaporation have been altering the seas’ saltiness and freshness. The system of currents takes 1,000 years to go full cycle. Warm water is chilled in the far North Atlantic and sinks. The cold, salty current flows south near the bottom.

As average temperatures rise worldwide, glaciers and sea ice are melting, and evaporation and precipitation patterns are shifting. With more freshwater pouring into some regions and more evaporation occurring in others, parts of the ocean are becoming fresher, while others are becoming saltier at a visible pace. Studies indicate that tropical Atlantic and Pacific waters have become saltier, while Arctic waters have become fresher. In one study, authors Ruth Curry (of the Woods Hole Oceanographic Institution) and Cecilie Mauritzen (of the Norwegian Meteorological Institute) suggest that, by the end of the century, the freshening of Northern Atlantic waters could slow or disrupt the ocean conveyor.

From 1965-95, a volume of freshwater almost as large as that in the Great Lakes melted from the glaciers in the Arctic and flowed into the normally salty North Atlantic. That nearly is 20,000 cubic kilometers of freshwater. By comparison, the entire outflow from the Mississippi River each year is about 500 cubic km. If the North Atlantic loses too much salinity, one of the primary forces driving circulation could weaken. Since fresher water is less dense, it does not sink in saltier water. If waters were to stop sinking in the North Atlantic, existing currents could slacken or change course, leading to altered climate patterns. A slackening of the conveyor could slow or change the course of the Gulf Stream-a warm current that gives northwestern Europe a milder climate than it normally would have so far north-plunging Europe into a colder era even as the rest of world experiences warmer temperatures, more droughts, and excess flooding. Circulation patterns also deliver nutrientrich waters to strategic parts of the ocean. A disruption of the ocean conveyor would interfere with this delivery system of nutrient supplies to sea animals and could have dire consequences for the intricate web of marine life. As surface waters heat up, the vertical layers of sea water could mix less with each other, an effect called vertical stratification. Upwellings of cold, nutrient- rich waters would become less frequent, thus diminishing blooms of phytoplankton, microscopic plants that anchor the marine food chain. On top of that, phytoplankton use carbon dioxide for photosynthesis. If plankton become depleted, the oceans could not remove as much carbon dioxide from the atmosphere.

The marine food chain already may be showing signs of breaking down. In 2005, on the West Coast of the U.S., and, in 2004, in Great Britain, hundreds of thousands of seabirds failed to breed. Dead cormorants and Cassin’s auklets have washed up on beaches. Juvenile rockfish counts are the lowest they have been off California in more than 20 years. Most alarming, small crustaceans like krill-the base of the ocean’s food web-have suffered steep declines.

The culprit for the collapse appears to be slackening upwellings, which have decreased phytoplankton blooms in these coastal areas. Fewer phytoplankton mean fewer fish, leaving the birds to face mass starvation. Scientists speculate that this decrease in food supply could be an effect of global warming. With no mixing, nutrients at the surface would be used up in about 50 years. Beyond that, “Deep waters would be deprived of oxygen and food from the surface,” emphasizes Fujita, “and many deep sea animals could be affected.” Monitoring of ocean waters off Hawaii over the last 20 years shows that waters in the area are indeed more stratified and upwellings are decreasing.

El Nino events are natural variations in weather patterns that normally occur about every four or five years and last for one to two years. They are tied to trade winds. This peculiar weather pattern sometimes triggers severe weather changes across the Pacific Ocean and other parts of the world. During an El Nino, patches of unusually warm water develop in the tropical Pacific near the Galapagos Islands off South America. Weaker trade winds cause fewer upwellings and less deep mixing of cold and warm waters. El Ninos promote warmer ocean and land temperatures. “Such a strong global event has profound effects,” notes Fujita. For one, productivity in tropical waters drops. The nutrient-poor warm water does not fuel the food web like the nutrient-rich cold water from the deep does.

Pacific salmon populations fell sharply during a strong El Nino in 1997-98, when ocean temperatures rose 6[degrees]. Many rockfish species did not fare well, either, although there were some winners during the same event. Pacific hake, cod, herring, and sardines reproduced well. During the same period, the most widespread and severe coral bleaching event on record took place.

Rainfall and evaporation patterns change during an El Nino. Many normally arid areas get more rainfall and heavy thunderstorms: to wit, California and Peru often experience heavy rainfall and flooding, while normally wet Indonesia may suffer drought and massive forest fires. El Ninos have become more frequent since 1976. Many ocean specialists say that these events possibly will occur more frequently and last longer as the Earth heats up.

Warmer waters already are affecting marine life. “Shifts in distributions of fish and other creatures are one impact of global warming that is pretty obvious,” according to Fujita. For example, off the coast of central California near Monterey over the last 60 years, southern warm water species generally have increased in abundance, while northern cold water species have declined. From 1951-93, water temperatures rose an average of 2.7[degrees] and Zooplankton declined by 70%. During that same period, Pacific salmon fisheries collapsed. Warmer waters and poor fisheries management were contributors. Sea birds, fur seals, sea lions, and gray whales died in unusually high numbers during record warm years since there was less plankton.

Shifting habitats

Doug Rader is studying the Albemarle and Pamlico sounds in North Carolina to see “what global warming means for real places.” He sees evidence that Atlantic species of fish are responding to changes in water temperatures. “We’ve seen a decline in black sea bass in southeast U.S. waters but, farther north, black sea bass is more abundant.” Rader also is witnessing large increases in Gray triggerfish, a warm water reef fish, and, as noted earlier, he and other ocean specialists have spotted larvae of butterfly fish, angelfish, and other tropical species floating in northern coastal waters. “These kinds of larvae would normally be killed off by the cold, although we don’t know if, over the long term, these species will survive in higher-latitude waters.”

As waters warm, the more native species’ ranges are likely to shift and habitats become more vulnerable to invasive non-native species. “We do know that waters in the mid Atlantic are now suitable for exotic invasive tropical species to survive without natural predators,” continues Rader. Populations of Pacific red lion fish, a “big showy venomous fish popular for saltwater aquariums,” have exploded in the mid Atlantic, apparently escaping in large enough numbers to thrive. “This fish was not around in the 1980s, and they are now breeding from Florida to North Carolina,” Rader reports.

Rising seas also will have cascading effects on fish habitats, insists Rader. In North Carolina, the sea level has risen by slightly more than one foot since the 1920s, a rate of 1.5 feet per century. Scientists say the rate will double within a century. As seas rise, more salt water will penetrate fresh and brackish sounds, converting freshwater into brackish water, and brackish marsh into salt marsh. It also will “drown” some marshes that cannot keep up with the rising waters. These changes could devastate key feeding and nursery grounds from Florida to Maine for a wide variety of marine life, including dolphins, snappers, shad, and river herring. This means “profound consequences for the commercial and recreational fisheries sustained by these estuaries,” proclaims Rader.

Slackening upwellings of nutrient-filled waters on the West Coast have had dire consequences for fish and seabirds. In July 2005, The San Francisco Chronicle reported that “plankton have largely disappeared from the waters off Northern California, Oregon, and Washington” and, in “perhaps the most ominous development, seabird nesting has dropped significantly on the Farallon Islands off San Francisco, the largest Pacific Coast Seabird rookery south of Alaska.” The collapse of the nesting season has not been seen in the 30 years of record-keeping for the islands’ seabirds. In 2004, hundreds of thousands of Scottish seabirds failed to breed, which never has happened in the time that they have been monitored. Scientists link this phenomenon to global warming, specifically the dearth of phytoplankton blooms. Fish starve, leaving no food for seabirds. “If this trend continues, that does not bode well for many fish and seabirds,” cautions Wang.

Coral reefs are taking hits around the world from many stresses- pollution, destructive fishing practices, disease-but perhaps the most damaging is warmer water. Corals host tiny algae called zooxanthellae that give them their color as well as a food source. When stressed by excessive heat or cold, many corals expel their algae and “bleach.” Corals are very sensitive to temperature changes and thrive within a narrow band of heat and cold: a temperature increase of 1.8[degrees] can trigger them to bleach. After severe bleaching, they often die.

A mass bleaching of corals occurred during a very warm 1997-98. About 16% of the world’s reefs seriously were damaged. Coral reefs that had persisted for as long as 1,000 years simply perished. Continued wanning could make mass bleachings an annual event. “Within a century,” asserts Doug Rader, “very large portions of coral reefs could be gone.” Rader has spent years diving and snorkeling in the Caribbean and has seen firsthand the decimation to reefs: “The damage is bad enough from coral and sea urchin disease, which has nearly destroyed elkhom and staghorn reefs throughout the region; then you add to that more frequent bleaching events and the fact the seas are unable to support reef-forming coral because waters are absorbing too much carbon dioxide. It seems hard to believe that it is happening-and happening on our watch.”

Yet, there remains a sliver of hope. “Corals are sensitive but also very resilient-if conditions are right,” relates Fujita. “If we can reduce some of the other direct stresses from human activities on coral reefs, like pollution from nonpoint sources, perhaps that may also enable reefs to cope better with indirect threats like climate change.”

Creating more protected areas for coral reefs may help them better withstand the rigors of too-warm water and be less vulnerable to mass bleachings. Kelp forests seem to be able to cope with warmer water better in marine reserves but, even so, cautions Fujita, “The number of corals that can adapt to or withstand such dramatic, rapid changes may be just a tiny fraction-coral reefs may likely prove to be the first ecological victims of unchecked global warming.”

Besides the incalculable loss of these “rain forests of the ocean” and the colorful reef fish, turtles, sharks, lobsters, shrimp, sea urchins, sea stars, anemones, and sponges that depend on them, the economic losses would be enormous in regions that depend on reefs for food and tourism income. Coral reefs provide an estimated $375,000,000,000 in economic benefits each year globally. Coral reefs face yet another threat induced by carbon dioxide pollution. A 2005 report by the U.K.’s Royal Society found that the increased CO^sub 2^ being absorbed by the ocean over the last two centuries is making it more acidic. When carbon dioxide dissolves into the ocean, it produces carbonic acid, which corrodes the limestone structures of coral reefs and shells of marine organisms. “The world’s seas are naturally alkaline,” explains Fujita, “and thousands of marine animals have evolved and flourished for eons in this environment. Many of these creatures will not survive in an acid sea.” In acidic water, “there is a greater tendency for seashells to dissolve, like putting them in vinegar, but not quite as dramatic,” explains Wang.

Tropical reefs in danger

As waters become more acidic, coral reefs and other marine ecosystems could suffer. The report’s panel of scientists points out that acidification hurt tropical and subtropical reefs the most, but that cold water corals are in danger as well. Since acidification is “irreversible in our lifetimes, the only practical step is to reduce emissions of carbon dioxide as quickly as possible to minimize large- scale, long-term harm to the world’s oceans and marine ecosystems,” the report warns.

The debate over global warming has shifted from whether it is happening to how to avoid catastrophic damage. “We’re facing warming waters and major alterations in many oceanic processes and ocean chemistry, damage to coral reefs, and effects from sea level rise on marine ecosystems,” affirms Doug Rader. “These are impacts we need to plan for and develop strategies for adaptation.” Rader, who played a key role in developing North Carolina’s Coastal Habitat Protection Plan, says similar “road maps” are needed for all coastal regions around the country-and ultimately the world. He is working on a blueprint for Pamlico and Albemarle sounds to project scenarios of how sea level rise, changing habitats, invasion of exotic species, pollution, and other impacts of human intervention will play out by the end of the century. “The bottom line is that the area will not look like what it does now-but what it will look like and what we can do to limit the damage is the big question?”

Rader is optimistic that North Carolina is up to the challenge and sees the state as one of the leaders in planning for broad- scale changes to ocean ecosystems. The South Atlantic Fishery Management Council has drafted the first-ever fishery ecosystem plan and the state passed a landmark bill to address climate change. Above all, Rader entreats, we need to invest in a new vision of the future-a national commitment to tackle climate change, one that engages diverse groups of stakeholders all working toward a common interest that seeks to balance economic gains with low-impact development and protection of critical habitats. “This would be an engagement similar to the plan to restore and protect the Everglades ecosystem, which was really quite remarkable in that so many different kinds of people managed to agree and get the plan off the ground”

For its part, Environmental Defense partnered with The Nature Conservancy and commercial fisherman to create no-trawl zones off California. (Trawlers are huge fishing boats that drag nets across the sea floor and damage habitat and catch sea life that is not used commercially.) Together, these groups protected nearly 4,000,000 acres of spectacular underwater habitat, from deep canyons and seamounts to coral gardens and reefs. The groups shared information on where the fish were and where the reserves should be. The protection of this vast area shows that bringing diverse groups together to forge creative solutions can work even on problems that seem impossible to solve. As broad and complex a challenge as global warming is, with a commitment to action, we can find ways to cope and head off the worst impacts.

Another tactic is to lessen other threats to marine ecosystems, especially in locales rich in biodiversity. Reducing destructive fishing practices, keeping habitats healthy, and curbing pollution may help sea life withstand global warming impacts. Creating marine protected areas (MPAs) based on careful scientific assessments can assist in buffering ecosystems as well. “We can help manage for resilience by working into protection plans factors such as siting the protected area around coral reefs known to be most resilient to warm water, and designating migration zones or migratory corridors for fish and marine plants, like those for land animals,” declares Fujita, a member of the Federal advisory committee working on a national network of MPAs.

Yet, all these measures only may serve merely to soften the blow of climate change if we do not act quickly to reduce emissions of carbon dioxide. “There is no question we need more money invested in ocean research-it is grossly underfunded,” argues Rader, “and there is so much about the oceans we don’t know. We need more high- quality data on fisheries and ecosystems, and we need more extensive monitoring to take the pulse of the ocean-that is, to measure temperature, salinity, currents, and biological processes.”

Still, we know enough today to take action now to address global warming. “Humanity may have only a narrow window of time leftperhaps a decade or so-to begin the emissions reduction needed to stabilize greenhouse gas concentrations at a level that can avert devastating and irreversible impacts from global warming,” Wang concludes.

“As average temperatures rise . . . glaciers and sea ice are melting, and evaporation and precipitation patterns are shifting. With more freshwater pouring into some regions and more evaporation occurring in others, parts of the ocean are becoming fresher, while others are becoming saltier at a visible pace.”

“Coral reefs are taking hits around the world from many stresses- pollution, destructive fishing practices, disease-but perhaps the most damaging is warmer water. . . . When stressed by excessive heat or cold, many corals expel their algae and ‘bleach.'”

“Reducing destructive fishing practices, keeping habitats healthy, and curbing pollution may help sea life withstand global warming impacts. Creating marine protected areas (MPAs) based on careful scientific assessments can assist in buffering ecosystems as well.”

David Festa is oceans program director for Environmental Defense, Washington, D.C. This article was adapted from the organization ‘s “Oceans Alive ” report.

Copyright Society for Advancement of Education Sep 2008

(c) 2008 USA Today; New York. Provided by ProQuest LLC. All rights Reserved.

Foolishly Seeking Gender Equity in Math and Science

By Sommers, Christina Hoff

“The business community and citizens at large completely are in the dark. This is a quiet revolution. Its weapons are government reports that rarely are seen; amendments to Federal bills that almost no one reads; small, unnoticed, but dramatically consequential changes in the regulations regarding government grants; and congressional hearings attended mostly by true believers.” MATH 55 IS ADVERTISED in the Harvard University catalog as “probably the most difficult undergraduate math class in the country.” It is a notoriously difficult course that does not look like America. Each year, as many as 50 individuals sign up, but at least half drop out within a few weeks. As one former pupil told The Crimson newspaper in 2006, “We had 51 students the first day, 31 students the second day, 24 for the next four days, 23 for two more weeks, and then 21 for the rest of the first semester.” Said another, “I guess you can say it’s an episode of ‘Survivor’ with people voting themselves off.” The final class roster, according to The Crimson: “45 percent Jewish, 18 percent Asian, 100 percent male.”

Why do women avoid classes like Math 55? Why, in fact, are there so few women in the high echelons of academic math and in the physical sciences? Women now earn 57% of bachelors degrees and 59% of masters degrees. According to the Survey of Earned Doctorates, 2006 was the fifth year in a row in which the majority of research Ph.D.s awarded to U.S. citizens went to women, who earn more Ph.D.s than men in the humanities, social sciences, education, and life sciences. Elsewhere, though, the figures are different. Women comprise just 19% of tenure-track professors in math, 11 % in physics, and 10% in computer science and electrical engineering. Moreover, the pipeline does not promise statistical parity anytime soon; women are earning 24% of the Ph.D.s in the physical sciences- way up from the four percent of the 1960s, but still far behind the rate they are winning doctorates in other fields. “The change is glacial,” notes Debra Rolison, a physical chemist at the Naval Research Laboratory. Rolison and others want to apply Title IX to science education.

Title IX, the celebrated gender equity provision of the Education Amendments Act of 1972, so far has been applied mainly to college sports, but the measure is not limited to athletics. It provides, “No person in the United States shall, on the basis of sex … be denied the benefits of … any education program or activity receiving federal financial assistance.”

While Title DC has been effective in promoting women’s participation in sports, it also has caused serious damage, in part because it has led to the adoption of a quota system. Over the years, judges, Department of Education officials, and college administrators have interpreted Tide DC to mean that women are entitled to “statistical proportionality.” That is to say, if a college’s student body is 60% female, then 60% of the athletes should be female-even if far fewer women than men are interested in playing sports at that college. Yet, many athletic directors have been unable to attract the same proportion of women as men. To avoid government harassment, loss of funding, and lawsuits, they simply have eliminated men’s teams. Although there are many factors affecting the evolution of men’s and women’s college sports, there is no question that Title IX has led to men’s participation being calibrated to the level of women’s interest. That kind of calibration could devastate academic science.

Unfortunately for academia, equity activists such as Rolison are not alone in their eagerness to apply TiUe DC to the sciences. On Oct. 17, 2007, a subcommittee of the House Committee on Science and Technology convened to learn why women are “underrepresented” in academic professorships of science and engineering and to consider what the Federal government should do about it.

Why women tend to gravitate to fields such as education, English, psychology, and biology, while men are much more numerous in physics, mathematics, computer science, and engineering is an interesting question-and the subject of a substantial amount of empirical literature. Yet, there were no disagreements on the matter at the congressional hearing. All five “expert” witnesses, and all five congressmen, Democrat and Republican, were in complete accord. They attributed the dearth of women in university science to a single cause: pervasive sexism. There was no dispute about the solution, either. All agreed on the need for a revolutionary transformation of American science itself. “Ultimately,” notes Kathie Olsen, deputy director of the National Science Foundation (NSF), “our goal is to transform, institution by institution, the entire culture of science and engineering in America, and to be inclusive of all-for the good of all.”

The first witness was Donna Shalala. She had chaired the “Committee on Maximizing the Potential of Women in Academic Science and Engineering,” organized by several leading scientific organizations, including the National Academy of Sciences (NAS), Academy of Engineering, and Institute of Medicine. In 2006, the committee released a report, “Beyond Bias and Barriers: Fulfilling the Potential of Women in Academic Science and Engineering,” that claimed to find “pervasive unexamined gender bias.” It received lavish media attention and has become the standard reference work for the “STEM” gender-equity movement (the acronym stands for science, technology, engineering, and math).

A hostile climate

At the hearing, Shalala warned that strong measures would be needed to improve the “hostile climate” women face in the academy. This “crisis,” as she called it, “clearly calls for a transformation of academic institutions. . . . Our nation’s future depends on it.” Shalala and other speakers called for rigorous application of Title IX and other punitive measures.

A centerpiece of STEM activism is the idea that science, as currently organized and practiced, intrinsically is hostile to women and a barrier to the realization of their unique intellectual potential. Massachusetts Institute of Technology biologist Nancy Hopkins, an effective leader of the science equity campaign, points to the hidden sexism of the obsessive and competitive work ethic of institutions like MIT. “It is a system,” Hopkins maintains, “where winning is everything, and women find it repulsive.” This viewpoint explains the constant emphasis-by equity activists such as Shalala, Rolison, and Olsen-on the need to transform the “entire culture” of academic science and engineering. The notion that the success of females in science depends on changing the rules of the game seems demeaning to women-but it gives the STEM-equity movement extraordinary scope, commensurate with the wide-ranging power that Federal science funding would put at its disposal.

Already, the National Science Foundation is administering a multimillion-dollar gender-equity program called ADVANCE, which, as Olsen told the subcommittee, aims to transform the culture of American science to make it gender-fair. Through ADVANCE, NSF is attempting to make academic science departments more cooperative, democratic, and interdisciplinary as well as less obsessive and stressful.

These proposed solutions assume a problem that might not exist. If numerical inferiority were sufficient grounds for charges of discrimination or cultural insensitivity, Congress should be holding hearings on the crisis of underrepresentation of men in higher education. After all, women earn most of the degrees-practically across the board. What about male proportionality in the humanities, social sciences, and biology? The physical sciences are the exception, not the rule.

So, why are there so few women in the high echelons of academic math and in the physical sciences? In a recent survey of faculty attitudes on social issues, sociologists Neil Gross of Harvard and Solon Simmons of George Mason University asked 1,417 professors what accounts for the relative scarcity of female professors in math, science, and engineering. Just one percent of respondents attributed the scarcity to women’s lack of ability, 24% to sexist discrimination, and 74% to differences in what characteristically interests men and women. Many experts who study male-female differences provide strong support for that 74% majority. Readers can go to books like David Geary’s Male, Female: The Evolution of Human Sex Differences (1998); Steven Pinker’s The Blank Slate: The Modem Denial of Human Nature (2002), and Simon Baron-Cohen’s The Essential Difference: The Truth about the Male and Female Brain (2003) for arguments suggesting that biology plays a distinctive- but not exclusive-role in career choices.

Baron-Cohen is one of the world’s leading experts on autism, a disorder that affects far more males than females. Autistic persons tend to be socially disconnected and unaware of the emotional states of others, but they often exhibit obsessive fixation on objects and machines. Baron-Cohen suggests that autism may be the far end of the male norm-the “extreme male brain,” all systematizing and no empathizing. He believes that men are, “on average,” wired to be better systematizers and women to be better empathizers. It is a daring claim-but he has data to back it up, presenting a wide range of correlations between the level of fetal testosterone and behaviors in girls and boys from infancy into grade school. Despite two major waves of feminism, women still predominate-sometimes overwhelmingly-in empathy-centered fields such as early-childhood education, social work, veterinary medicine, and psychology, while men are overrepresented in the “systematizing” vocations such as car repair, oil drilling, and electrical engineering.

The research emphasizing the importance of biological differences in determining women’s and men’s career choices is not decisive, but it is serious and credible. So the question arises: How have so many officials at NSF and NAS and so many legislators been persuaded that we are facing a science crisis that Tide DC enforcement and gender- bias workshops can resolve? The answer involves a body of feminist research that purports to prove that women suffer from “hidden bias.” Regrettably, the three recognized canons of the literature are, in key respects, travesties of scientific method, and they have been publicized and promoted in ways that have ignored elementary standards of transparency and objectivity.

We begin with the famous, and mysterious, MIT study. In 1994, 16 senior faculty women, led by Hopkins, complained to the administration about sex discrimination in their various departments. MIT’s president, Charles Vest, and the dean of the School of Science, Robert Birgeneau, dutifully set up a committee to review the complaints but, rather than bring in outsiders, they put the protesters (joined by three male administrators) in charge of investigating their own grievances. Under Hopkins’ leadership, the committee produced a 150-page study that found MTT guilty on all counts. The report was deemed “confidential” and “sensitive” and, to this day, it never has been made public.

What was released to the press, in March 1999, was a brief summary of the report’s findings, along with letters from Vest and Birgeneau admitting guilt. As The Chronicle of Higher Education reported, “MTT released a cursory report of the study it conducted, so it is difficult for outsiders to judge what the gap was between men and women.” The New York Times carried the story on the front page under the headline, “MTT Admits Discrimination Against Female Professors.” Prof. Hopkins soon was everywhere in the press and, on April 8, 1999, was invited to attend an Equal Pay Day event at the White House. Referring to Hopkins and her team, Pres. Bill Clinton stated, “Together they looked at cold, hard facts about disparity in everything from lab space to annual salary.”

However, cold, hard facts had little to do with it. University of Alaska psychologist Judith Kleinfeld concludes, “The MTT report presents no objective evidence whatsoever to support claims of gender discrimination in laboratory space, salary, research funds, and other resources.” Readers are told in the summary report that women faculty “proved to be underpaid,” but we also learn (hat the “salary data [is] confidential and [was] not provided to the committee.” So, on what basis did they conclude there were salary disparities? Hopkins and the other authors explain, “Possible inequities in salary are flagged by the committee from the limited data available to it.” The trouble is, “possible” soon became “actual” and, by the time it reached Pres. Clinton, it had morphed into “cold, hard facts.”

What discrimination?

Mathematics professor Daniel Kleitman, one of the three males on the Hopkins committee, told the Chronicle that he “never saw any evidence” of discrimination against women. When a reporter from The Chronicle of Higher Education asked Mary-Lou Pardue, an MTT biology professor who was among those who originally complained to the dean, about all the irregularities and the absence of data, she replied, ‘This wasn’t meant to be a study for the rest of the world. It was meant to be a study for us. . . . We weren’t trying to prove anything to the world.” The world, though, thought otherwise, and when a Wall Street Journal editorial faulted the study, Vest and Birgeneau sent a letter claiming that the work of their committee had “successfully identified the root causes of a fundamental failure in American academia.” As a direct result of the MIT report, the Ford Foundation, along with an anonymous donor, came forward with grants in excess of $1,000,000 to fund more equity studies and to promote more initiatives to fight gender bias in academic science- and then NSF followed suit with its ADVANCE institutional transformation campaign.

In May 1997, the distinguished British journal Nature published a provocative article titled, “Nepotism and Sexism in Peer-Review.” The authors, Christine Wenneras and Agnes Wold, two Swedish scientists from the University of Goteborg, claimed to have found blatant gender bias in the peer-review system of the Swedish Medical Research Council. After reviewing the relevant data, they concluded that, to win a postgraduate science fellowship, a female applicant had to be at least twice as good as a male applicant The Wenneras- Wold article caused a sensation in Europe and the U.S., and now is a staple in the gender-equity literature. A recent article in Scientific American referred to it as the one and only “thorough study of the real-world peer-review process” and judged its findings “shocking.” The Shalala-NAS “Beyond Bias” report describes the piece as a “powerful” tool for educating provosts, department chairs, and search committees about bias.

Yet, what does the article actually show? Wenneras and Wold investigated the peer-reviewing practices of the Medical Research Council in 1994 after they both had been denied postgraduate fellowships. The Swedish study, unlike the MIT report, actually was published, and it presents data and describes its methodology, but there are serious grounds for skepticism: once again, it was a case of women investigating their own complaints; furthermore, what they concluded seemed a bit improbable. According to their calculations, to score as well as a man, a woman had to have the equivalent of three extra papers published in world-class science journals such as Science or Nature or 20 extra papers in leading specialty journals such as Radiology or Neuroscience.

I sent the Swedish study to two research psychologists, Jerre Levy (professor emerita, University of Chicago) and James Steiger (professor and director, Quantitative Methods and Evaluation, Department of Psychology and Human Development, Vanderbilt University) for their review. They both immediately zeroed in on some troubling methodological anomalies: though it is unlikely that any one variable adequately characterizes academic productivity, Wenneras and Wold analyzed each productivity variable individually instead of using an inclusive regression formula that analyzes all productivity variables simultaneously. Steiger wrote to Wenneras and Wold requesting copies of the data so he could review it himself. Wold wrote back that she gladly would send the data, except that it had gone missing.

Certainly, researchers occasionally lose data, but this was pretty special data: the researchers had invested substantial time and the expense of a lawsuit to obtain it, and it was the basis of a highly celebrated study with singular findings. Even assuming that the research held up, however, it is odd that a single study of postgraduate fellowships at a Swedish university should play such a prominent role in a campaign to eliminate “hidden bias” in American universities.

When NSF carried out a review of its own grant-review process in the U.S. in 1997, it found no evidence of bias against women. In 1996, for example, it approved grants from approximately 30% of female applicants and 29% of male applicants. A formal outside study, performed in 2005 by the RAND Corporation (titled “Is there Gender Bias in Federal Grants Programs?”) reached the same conclusion: “Overall, we did not find gender differences in federal grant funding outcomes in this study.”

Unlike the Swedish study, however, the RAND study did not make it to the NSF/NAS list of essential literature on gender bias. Two other items in the “top four” are weak statistical studies of marginal issues that never have been evaluated rigorously.

A final item in the STEM-equity canon is a book by feminist Virginia Valian that purports to be scientific, but is not. Valian, a psychologist at Hunter College, is one of the most cited authorities in the crusade to achieve equity for women in the sciences. Her 1998 book Why So Slow? is indispensable to the movement because it offers a solution to a vexing problem: women’s seemingly free but actually serf-defeating choices. Her central claim is that our male-dominated society constructs and enforces “gender schemas.” A gender schema is an accepted system of beliefs about the ways men and women differ-a system that determines what suits each sex. Writes Valian: “hi white, Western middle-class society, the gender schema for men includes being capable of independent, autonomous action [and being] assertive, instrumental, and task-oriented. Men act. The gender schema for women is different; it includes being nurturant, expressive, communal, and concerned about others.”

Valian does not deny that gender schemas have a foundation in biology, but she insists that culture can intensify or diminish their power and effect. Our society, she adds, pressures women to indulge their nurturing propensities while it encourages men to develop “a strong commitment to earning and prestige, great dedication to the job, and an intense desire for achievement.” All this inevitably results in a permanently unfair advantage for men. To achieve a gender-fair society, Valian advocates a concerted attack on conventional gender schemas. This includes altering the way we raise our children. Consider the custom of encouraging girls to play with dolls. Such early socialization, she argues, creates an association between being female and being nurturing. Valian concludes, Egalitarian parents can bring up their children so that both boys and girls play with dolls and trucks. . . . From the standpoint of equality, nothing is more important.” In the face of resistance, Valian advocates perseverance. “We don’t accept biology as destiny. . . . We vaccinate, we inoculate, we medicate. . . . I propose we adopt the same attitude toward biological sex differences.” In other words, the ubiquitous female propensity to nurture should be treated as a kind of disorder or disease. Valian’s views are a guiding light for some of the nation’s leading scientific institutions. Her book is trumpeted on the NSF/NAS ‘Top Research” list, and Valian herself has inspired NSF’s ADVANCE gender- equity program, hi 2001, NSF awarded Valian and her Hunter colleagues $3,900,000 to develop equity programs and workshops for the “scientific community at large.”

NSF has an annual budget of $5,900,000,-000 devoted to “promoting the progress of science” and “securing the national defense.” It is not easy to understand how NSF regards its ADVANCE program or its deep association with Valian as serving those goals. Since 2001, NSF has given approximately $107,000,000 to 28 institutions of higher learning to develop transformation projects. Hunter College, the site of Valian’s $3,900,000 program, is one of them. The University of Michigan also has received $3,900,000; Cornell University, $3,300,000; and the University of Puerto Rico at Humacao, $3,100,000.

What are these schools doing with the money? Some of the funds are being used for relatively innocuous-possibly even beneficial- projects such as mentoring programs and conferences, but there are worrisome initiatives as well. Michigan is experimenting with “interactive” theater as a means of raising faculty consciousness about gender bias. At special workshops, physicists and engineers watch skits where overbearing men ride roughshod over hapless-but obviously intellectually superior-female colleagues. The writer- director, Jeffrey Steiger of the university’s theater program, explains that the project is inspired by Brazilian director Auguste Boal’s book Theatre of the Oppressed (1974). Some audience members will find the experience “threatening and overwhelming,” and Steiger aims to provide them a “safe” context for expressing themselves.

The play’s the thing

NSF showcases this program as a “tried and true” success story. Michigan is not alone in using theater to advance the progress of science. The University of Puerto Rico at Humacao devoted some of its NSF-ADVANCE grant to co-sponsor performances of Eve Ensler’s raunchy play “The Vagina Monologues,” a celebration of women’s intimate anatomy. The University of Rhode Island lists among its ADVANCE “events” a production of “The Vagina Monologues,” along with a visit by Valian. More mainstream schools are using their ADVANCE funds more conventionally-to initiate quota programs. At Cornell, as of 2006, 27 of 51 science and engineering departments had fewer than 20% women, and some had no women at all. It is using its NSF grant for a program called ACCEL (Advancing Cornell’s Commitment to Excellence and Leadership), dedicated to filling science faculty with “more than” 30% women in time for the university’s sesquicentennial in 2015.

Sensible people will be inclined to dismiss the ADVANCE programs, the enthusiastic promotion of weak and tendentious bias studies, and the blustering senators and congressmen as an inconsequential sideshow in the onward march of mighty American science and technology. NSF, like any government agency with a budget of $6,000,000,000, can be expected to spill a few million here and there on silly projects and on appeasing noisy constituent groups. However, the STEM-equity campaign is not going to rest with a few scientific bridges-tonowhere. For one thing, the Title IX compliance reviews already are underway. In the spring of 2007, the Department of Education evaluated the Columbia University physics department. Cosmology professor Amber Miller was required to make an inventory of all the equipment in the lab and indicate whether women were allowed to use various items. She told Science Magazine: “I wanted to say, leave me alone, and let me get my work done.” However, Miller and her fellow scientists are not going to be left alone. Equally ominous is the fact that NSF and NAS-the U.S.’s most prestigious and influential institutions of science-already have made significant concessions to the STEM-equity ideology. So have MIT and Harvard.

The power and glory of science and engineering is that they are, adamantly, evidencebased, but the evidence of gender bias in math and science is flimsy at best, and the evidence that women are relatively disinclined to pursue these fields at the highest levels is serious. When the bastions of science pay obsequious attention to the flimsy and turn a blind eye to the serious, it is hard to maintain the view that the science enterprise somehow is immune to the enthusiasms that have corrupted other, supposedly “softer” academic fields.

Few academic scientists know anything about the equity crusade. Most have no idea of its power, its scope, and the threats that they soon may be facing. The business community and citizens at large completely are in the dark. This is a quiet revolution. Its weapons are government reports that rarely are seen; amendments to Federal bills that almost no one reads; small, unnoticed, but dramatically consequential changes in the regulations regarding government grants; and congressional hearings attended mostly by true believers.

American scientific excellence is a precious national resource. It is the foundation of our economy and of the nation’s health and safety. Norman Augustine, retired CEO of Lockheed Martin, and Burton Richter, Nobel laureate in physics, once pointed out that MIT alone- its faculty, alumni, and staff-started more than 5,000 companies in the past 50 years. Will an academic science that is quota-driven, genderbalanced, cooperative rather than competitive, and less time- consuming produce anything like these results? So far, no one in Congress even has thought to ask.

“Ultimately . . . our goal is to transform, institution by institution, the entire culture of science and engineering in America, and to be inclusive of all-for the good of all.”

“. . . It is odd that a single study of postgraduate fellowships at a Swedish university should play such a prominent role in a campaign to eliminate ‘hidden bias’ in [U.S.] universities.”

“The power and glory of science and engineering is that they are, adamantly, evidence-based, but the evidence of gender bias in math and science is flimsy at best. . . .”

Christina Hoff Sommers is a resident scholar at the American Enterprise Institute, Washington, D.C.

Copyright Society for Advancement of Education Sep 2008

(c) 2008 USA Today; New York. Provided by ProQuest LLC. All rights Reserved.

Tissue Factor, Tissue Pathway Factor Inhibitor and Risk Factors of Atherosclerosis in Patients With Chronic Limbs Ischemia: Preliminary Study

By Gosk-Bierska, I Wysokinski, W; Karnicki, K; Adamiec, R

Aim. Thrombus formation plays a critical role in pathogenesis of cardiovascular complications in atherosclerotic peripheral arterial occlusive disease (PAOD). Tissue factor (TF) initiates the clotting cascade and is considered an important regulator of hemostasis and thrombosis. TF activity is regulated by TF pathway inhibitor (TFPI). The aim of our study was to evaluate plasma levels of the TF, TFPI and their relation to coagulation system and various other risk factors of atherosclerosis in patients with chronic limbs ischemia. Methods. Plasma TF, total TFPI, truncated TFPI, full-length TFPI were assessed by ELISA using commercially available kits (IMUBIND Tissue Factor; Total TFPI; Truncated TFPI ELISA Kit; American Diagnostica Inc. Stamford) in 62 claudicant patients with PAOD and 20 healthy controls.

Results. We observed statistically higher levels of TF (94+-52 pg/ mL), total TFPI (43+-8 ng/mL), and truncated TFPI (22+-7 ng/mL) in patients with PAOD compared to healthy individuals (TF: 66+-15 pg/ mL; total TFPI: 36+-4 ng/mL; truncated TFPI: 14+-5 ng/mL). Full- length TFPI (20 +-4 ng/mL) is lower in patients with PAOD than in controls (23+-5 ng/mL). The study indicated a positive correlation between TF and truncated TFPI (r=0.34), total TFPI and full TFPI (r=0.5), total TFPI and truncated TFPI (r=0.83) in patients with PAOD, and negative correlation between full TFPI and truncated TFPI (r=-0.65) in the control.

Conclusion. Elevated levels of TF, disorders of balance between full-length TFPI and truncated TFPI as well as significantly increased truncated TFPI level in patients with PAOD can be independent risk factors of atherosclerotic complications.

[Int Angiol 2008;27:296-301]

Key words: Thromboplastin – Lipoprotein-associated coagulation inhibitor – Atherosclerosis – Arterial occlusive diseases.

Tissue factor (TF), a membrane glycoprotein found on endothelial cells, smooth muscle cells, white blood cells and in plasma, is considered an important regulator of hemostasis and thrombosis.1-3 After vascular injury, TF interacts with circulating factor VII, forming the active TF/VIIa complex which activates factor X. This process is more efficient in the presence of phospholipids and Ca- ions. P-selectins, certain cytokines, endotoxin and immune complexes stimulate monocytes and induce the TF expression on their surfaces.4 TF may contribute to the generation of coagulation proteases and the activation of protease activated receptors on vascular cells.5 Atherosclerotic plaques and monocytes can generate TF after stimulation with lipopolysaccharides or IL-1.6 TF plays an important role in the initiation of blood coagulation after plaque rupture in patients with acute coronary syndromes.79 TF activity is regulated by TF pathway inhibitor (TFPI). Alteration in TF and TFPI levels can influence thrombotic events. TFPI is secreted from platelets, endothelial cells, mesangial cells, smooth cells, monocytes, fibroblasts, cardiomyocytes.1012 TFPI is released into circulation after unfractionated or low molecular weight heparin injections in dose-dependent manner.13, 14 TFPI is a Kunitz-type protease inhibitor containing three domains. The first domain inhibits TF/ VIIa complex, the second one interacts with Xa, and the third domain contains highly positively charged carboxyl-terminus binding negatively-charged glycosaminoglycans including heparin. TFPI inhibits the proteolytic capacity of factor Xa by binding to the active site of Xa through its second Kunitz domain and then it inhibits the activity of TF/VIIa complex by forming a quaternary complex with TF/VIIa. The initial TFPI/Xa binding potentiates inhibition of the TF/VIIa complex by the first Kunitz domain. TFPI can also directly inhibit TF/VIIa/Xa complex in presence of Ca- ions.15 TFPI mediates downregulation of cell-surface TF in fibroblasts and monocytic cells via internalization and degradation by LDL receptor-related protein.16 The C-terminus region of TFPI contributes to modulation of cell proliferation. Enzyme immunoassays can distinguish between the free, lipoprotein-associated and endothelial cell-associated forms of TFPI.17 TFPI levels in plasma increase in patients with acute myocardial infarction/unstable angina.18, 19 The aim of our study was to evaluate plasma levels of the TF, TFPI and their relation to rheology, coagulation system and others risk factors in patients with atherosclerotic chronic limb ischemia.

Materials and methods

Sixty-two patients with intermittent claudication secondary to atherosclerotic peripheral arterial occlusive disease (PAOD) (stage 2 according to Fontaine) and 20 healthy individuals without risk factors of atherosclerosis were enrolled in the study. The diagnosis of PAOD was made based on positive history of claudication, positive findings on physical examination (bruits, absent or diminished pulses), and segmental blood pressure measurements (ankle-brachial index [ABI]

The study was approved by the Ethics Committee of the Wroclaw Medical University.

Blood was collected by the antecubital vein venipuncture. Blood samples for laboratory assays were obtained at approximately 8:00 a.m. after overnight fasting.

Plasma TF, total TFPI, truncated TFPI, full-length TFPI were assessed by ELISA using commercially available kits (IMUBIND Tissue Factor ELISA Kit no. 845; IMUBIND Total TFPI ELISA Kit no. 849; IMUBIND Truncated TFPI ELISA Kit no 850, American Diagnostica Inc., Stamford). Plasminalpha2-antiplasmin (PAP) complex, thrombin- antithrombin complex (TAT) were assessed by ELISA using commercially available kits (Enzygnost PAP micro-Dade Behring Marburg, Germany; Enzygnost TAT micro-Behring, Behringwerke AG Marburg, Germany). Plasma fibrinogen concentrations were measured by the coagulometric method (Fibrintimer II, Behring, Marburg, Germany using Multifiber). Platelet count, hemoglobin, hematocrit, hemoglobin A1c, plasma lipids, homocysteine, uric acid levels were elevated using routine procedures employed in our institution.

Statistical analysis

The statistical analyses were performed using STATISTICA 5,0PL. Statistical significance was accepted as P

Results

Sixty-two patients with PAOD and 20 healthy individuals were included in our study. Demographic data are presented in Table I. Both groups were gender- and age-matched. We observed statistically higher levels of TF (94+-52 pg/mL), total TFPI (43+-8 ng/mL), and truncated TFPI (22+-7 ng/mL) in patients with POAD compared to healthy individuals (TF: 66+-15 pg/mL; total TFPI: 36+-4 ng/mL; truncated TFPI: 14+-5 ng/mL). Full-length TFPI (20+-4 ng/mL) was lower in patients with PAOD than in controls (23+-5 ng/mL) (Table II). Atherosclerotic risk factors such as diabetes, hypertension, hyperlipidemia, tobacco smoking, obesity had no influence on TF and TFPI levels in patients with PAOD (Table III). We did not observe differences in TF and TFPI levels in claudicants with and without diabetes, coronary heart disease, myocardial infarction, stroke, and endovascular procedures or vascular surgery reported in past medical history (Table IV). Present study indicates positive correlation between TF and truncated TFPI (r=0.34), total TFPI and full TFPI (r=0.5), total TFPI and truncated TFPI (r=0.83) in patients with PAOD. In the control group, only negative correlation between full TFPI and truncated TFPI (r=-0.65) was observed (Table V). Fibrinogen, TAT, PAP levels were significantly higher in patient with chronic limb ischemia compared to controls (Table VI). There was no significant correlation between TF or TFPI and fibrinogen, TAT, PAP, plasma lipids, uric acid, platelets count, THT, HT, BMI, smoking (cigarettes * years).

Discussion

Our study indicates higher plasma TF levels in patients with chronic limbs ischemia in stage 2 according to Fontaine in the course of atherosclerosis compared to controls. In the present study, total TFPI and truncated TFPI levels were significantly higher in PAOD group, but full-length TFPI levels were lower in claudicants compared to controls. We did not observe any differences in TF and TFPI levels between patients in PAOD group with and without coronary heart disease and/or myocardial infarction reported in prior medical history. In claudicants group, TF and TFPI levels were also similar in patients with and without stroke, endovascular procedures or vascular surgery in medical history. TF plasma levels did not correlate with atherosclerotic risk factors such as plasma lipids, fibrinogen, and uric acid. Our study found no influence of hypertension, hyperlipidemia, diabetes, obesity, tobacco habit, cigarettes/years index on TF plasma levels. The analysis of TF and TFPI relationship indicated only positive correlation between TF and truncated TFPI in patients with chronic limbs ischemia. We did not observe any significant correlation between TF and TFPI in controls. Higher levels of fibrinogen, TAT, PAP in PAOD patients found in the present study confirm our previous observations.20, 21 However, elevated TF levels did not correlate with these parameters in claudicating patients.

There are only a few data about the role of TF and TFPI in patients with chronic limb ischemia. Blann et al. found elevated levels of TF and lower levels of total TFPI in patients with PAOD compared to healthy individuals and have suggested that reduced levels of total TFPI and raised levels of TF may contribute to the process of atherogenesis and the increased risk of thrombosis in patients with cardiovascular disease.22 We observed lower full TFPI level in claudicants compared controls, but total and truncated TFPI levels were higher in patients with PAOD. Two TFPI variants: full- length TFPI and truncated TFPI have different inhibitory potentials.23-24 The full-length TFPI contains the C-terminal domain required for direct interactions with ApoB100 as well as cell surface glycosaminoglycans. Truncated TFPI lacks the Cterminus domain essential for its anticoagulant activity and required for optimal factor Xa inhibition and interaction with lipoproteins.25 Ettelaie et al. demonstrated that only the full-length TFPI was influenced by LDL oxidation which resulted in the loss of its anticoagulant function, probably due to its ability to associate with LDL, and that C-terminal truncated TFPI was not affected significantly by oxidation. Full-length TFPI may be partially degraded in blood to the truncated TFPI.26 The change of proportion between truncated and full-length TFPI in patients with PAOD observed in our study can increase the risk of atherosclerotic damage to arterial walls and/or thrombotic tendency mainly because truncated TFPI has reduced affinity to heparin and others proteoglicans and lipids. Mast et al. postulated that physiological concentration of TFI is not sufficient to control the TF procoagulant activity.27 Increased levels of TFPI in claudicating patients in our study can be a compensative reaction due to higher TF level. High TF activity contributes to the procoagulant activity of disrupted atherosclerotic plaque and the superimposed mural thrombus.28,29 Some studies show increased levels of plasma TF in patients with acute coronary syndrome8,9 and chronic coronary artery disease.30 Suefuji et al. postulates that higher plasma TF levels in patients with acute myocardial infarction and prodromal unstable angina compared patients with chronic stable angina may reflect enhanced intravascular procoagulant activity.9 As well TFPI can be involved in thrombus formation in patients with acute coronary syndromes. The lower total and free TFPI plasma levels in coronary sinus compared to TPFI levels in aorta before and after PTCA in patients with acute myocardial infarction and lack of these differences in patients with stable angina indicated the role of TFPI in hemostasis after acute vessel wall injury.31 The lack of significant difference between TF and TFPI level in claudicants with and without coronary heart disease in our study might be due to the fact that none of our patients had unstable angina or recent myocardial infarction during the study.

Some authors suggest the influence of atherosclerotic risk factors on TF and/or TFPI levels22, 32-35 Morange et al. indicated positive correlation between free TFPI and fibrinogen, von Willebrand factor, t-PA, thrombomodulin, and presence of diabetes, hypertension, obesity and hyperlipidemia in patients with cardiovascular risk factors. The positive correlation was found for total TFPI with LDL cholesterol and negative correlation with others parameters of metabolic syndrome.32 Our study did not reveal any correlation between fibrinogen, TAT, PAP, plasma lipids and TFPI. We also did not observe any influence of diabetes, obesity or hypertension on TFPI level in patients with PAOD. Hyperlipidemia may result in more TFPI being bound which makes it unavailable to antagonize the procoagulant properties of TF. Kawaguchi et al. found that free TFPI level is inversely correlated with HDL cholesterol in patients with coronary arterial disease.33 However, in our study we did not observe statistical differences between plasma lipids in claudicant patients with PAOD in whom hyperlipidemia had been diagnosed in 85% and control patients. This was probably due to effective statin therapy. It can explain lack of the correlation between TFPI and lipid levels in patients with PAOD. A few studies have demonstrated that smoking increases TF expression in atherosclerotic plaque,34,35 but we did not detect any differences in TF levels between smoking and non smoking patients with PAOD.

We are planning to observe patients with POAD for 2 years during which all cardiovascular events (myocardial infarction, stroke, endovascular procedures, and surgery) will be registered and correlation between TF and TFPI levels and thrombotic complications analyzed.

Conclusions

Elevated levels of TF, disorders of balance between full-length TFPI and truncated TFPI, and significantly increased truncated TFPI level in patients with PAOD can be independent risk factors of atherosclerotic complications.

Received on March 1, 2007; accepted for publication on June 10, 2007.

References

1. Nemerson Y. Tissue factor and hemostasis. Blood 1988;71:1-8.

2. Giensen PL, Rauch U, Borhmann B, Kling D, Roque M, Fallon J et al. Blood-borne tissue factor: another view of thrombosis. Proc Natl Acad Sci U S A 1999;96:2311-5.

3. Rauch U, Nemerson Y. Circulating tissue factor and thrombosis. Curr Opin Hematol 2000;7:273-7.

4. Celi A, Pellegrini B, Lorenzet R, De Blasi A, Ready N, Furie BC et al. P-selectin induces the expression of t factor on monocytes. Proc Natl Acad Sci U S A 1994;91:8767-71.

5. Mackman N. Role of tissue factor in hemostasis, thrombosis, and vascular development. Arterioscler Thromb Vasc Biol 2004;24:1015- 22.

6. Toschi V, Gallo R, Lettino M, Fallon JT, Gertz SD, Fernandez- Ortiz A et al. Tissue factor modulates the thrombogenicity of human atherosclerotic plaques. Circulation 1997;95:594-9.

7. Falciani M, Gori AM, Fedi S, Chiarugi L, Simonetti I, Dabizzi RP et al. Elevated tissue factor and tissue factor pathway inhibitor circulating levels in ischaemic heart disease. Thromb Haemost 1998;79:495-9.

8. Soejima H, Ogawa H, Yasue H, Suefuji H, Kaikita K, Tsuji I et al. Effects of enalapril on tissue factor in patients with uncomplicated acute myocardial infarction. Am J Cardiol 1996;78:336- 40.

9. Suefuji H, Ogawa H, Yasue H, Hirofumi M, Kaikita K, Soejima H et al. Increased plasma tissue factor levels in acute myocardial interaction. Am Heart J 1997; 134:253-9.

10. Caplice NM, Mueske CS, Kleppe LS, Peterson TE, Bronze GJ, Simari RD. Expression of tissue factor pathway inhibitor in vascular smooth muscle cells and its regulation by growth factors. Circ Res 1998;83:1264-70.

11. Peti L, Lenik, Dachet C, Moreau M, Champan J. Tissue factor pathway inhibitor is expressed by human monocyte-derived macrophages: relationship to tissue factor induction by cholesterol and oxidized LDL. Arterioscler Thromb Vasc Biol 1999;19:309-15.

12. Yamabe H, Osawa H, Inuma H, Kaizuka M, Tamura N, Tsunoda S et al. Tissue factor pathway inhibitor production by human mesangial cells in culture. Thromb Haemost 1996;76:215-9.

13. Bara L, Bloch MF, Zitoun D, Samama M, Collignon F, Frydman A et al. Comparative effects of enoxaparin and unfractionated heparin in healthy volunteers on prothrombotic consumption in whole blood during coagulation, and release of tissue factor pathway inhibitor. Clinical trial. Thromb Res 1993;69:443-52.

14. Sandset PM, Abilgaard U, Larsen ML. Heparin induces release of extrinsic coagulation pathway inhibitor (EPI). Thromb Res 1988;50:803-13.

15. Broze GJ, Girard TJ, Novotny WF. Regulation of coagulation by a multivalent Kunitz-type inhibitor. Biochemistry 1990;29:7539-46.

16. Hamik A, Setiadi H, Bu G, McEver RP, Morrissey JH. Down- regulation of monocyte tissue factor-mediated by TFPI and LRP. J Biol Chem 1999;274:4962-9.

17. Broze GJ, Lange GW, Duffin KL, MacPhail L. Heterogeneity of plasma tissue factor pathway inhibitor. Blood Coagul Fibrinolysis 1994;5:551-9.

18. Kamikura Y, Wada H, Yamada A, Shimura M, Hiyoyama K, Shiku H et al. Increased tissue factor pathway inhibitor in patients with acute myocardial infarction. Am J Haematol 1997;55:183-7.

19. Soejima H, Ogawa H, Yasue H, Suefuji H, Kaikita K, Nishiyama K et al. Heightened tissue factor associated with tissue factor pathway inhibitor and prognosis in patients with unstable angina. Circulation 1999;99:2908-13.

20. Gosk-Bierska I, Adamiec R, Alexewicz P, Wysokinski E. Coagulation in diabetic and non-diabetic claudicants. Int Angiol 2002;21:128-33.

21. Gosk-Bierska I, Adamiec R, Wysokinski WE. Plasmin-aipha2- antiplasmin complexes in diabetic and non-diabetic patients with peripheral arterial occlusive disease. J Thromb Haemost 2003;1 Suppl 1:961.

22. Blann A, Amiral J, Mc Collum Ch, Lip G. Differences in free and total tissue factor pathway inhibitor and tissue factor in peripheral artery disease compared to healthy controls. Atherosclerosis 2000;152:29-34.

23. Nordfang O, Bjorn SE, Valentin S, Nielsen LS, Wildgoose P, Beck TC et al. The C-terminus of tissue factor pathway inhibitor is essential to its anticoagulant activity. Biochemistry 1991;30:10371- 6.

24. Wesselschmidt R, Likert KM, Girard TJ, Wun TC, Bronze GJ. Tissue factor pathway inhibitor the carboxy-terminus is required for optimal inhibition of factor Xa. Blood 1992;79:2004-10.

25. Hansen JB, Huseby NE, Sandset PM, Svensson B, Lyngmo V, Nordy A. Tissue factor pathway inhibitor and lipoproteins: evidence for association with and regulation by LDL in human plasma. Arterioscler Thromb 1994;14:223-9.

26. Ettelaie C, Wilbourn BR, Adam J, James NJ, Bruckdorfer KR. Comparison of the inhibitory effects of apoB100 and tissue factor pathway inhibitor on tissue factor and the influence of lipoprotein oxidation. Arterioscler Thromb Vasc Biol 1999;19:1784-90.

27. Mast AE, Bronze GJ Jr. Physiological concentrations of tissue factor pathway inhibitor do not inhibit prothrombinase. Blood 1996;87:1845-50.

28. Mallat Z, Hugel B, Ohan J, Leseche G, Freyssinet JM, Tedgui A. Shed membrane microparticles with procoagulant potential in human atherosclerotic plaques: a role for apoptosis in plaque thrombogenicity. Circulation 1999;26:348-53. 29. Annex BH, Denning SM, Channon KM, Sketch MH, Stack RS, Morrissey JH et al. Differential expression of tissue factor protein in directional atherectomy specimens from patients with stable and unstable coronary syndromes. Circulation 1995;91:619-22.

30. Saito Y, Wada H, Yamamuro M, Inoue A, Shimura M, Hiyoyama K et al. Changes of plasma hemostatic markers during percutaneous transluminal coronary angioplasty in patients with chronic coronary artery disease. Am J Hematol 1999;61:238-42.

31. Golino P, Ravera A, Ragini M, Cirillo P, Piro O, Chiariello M. Involvement or tissue factor and tissue factor pathway inhibitor in coronary circulation of patients with acute coronary syndromes. Circulation 2003;108:2864-9.

32. Morange PE, Renucci JF, Charles MA, Aillaud MF, Giraud F, Grimaux M et al. Plasma levels of free and total TFPI, relationship with cardiovascular risk factors and endothelial cell markers. Thromb Haemost 2001;85:999-1003.

33. Kawaguchi A, Miyao Y, Noguchi T, Nonogi H, Yamagishi M, Miyatake K et al. Intravascular free tissue factor pathway inhibitor is inveresely correlated with HDL cholesterol and postheparin lipoprotein lipase proportional to apolipoprotein A-II. Arterioscler Thromb Vasc Biol 2000;20:251-8.

34. Matetzky S, Tani S, Kangavaris S, Dimayunga P, Yano J, Xu H et al. Smoking increases tissue factor expression in atherosclerotic plaques: implications for plaque thrombogenicity. Circulation 2000;102:602-4.

35. Holschermann H, Terhalle H, Zakel U, Maus U, Parviz B, Tillmanns H et al. Monocyte tissue factor expression is enhanced in woman who smoke and use oral contraceptives. Thromb Haemost 1999;82:1614-20.

I. GOSK-BIERSKA 1, W. WYSOKINSKI 2, K. KARNICKI2, R. ADAMIEC 1

1 Unit of Angiology, Hypertension and Diabetology, Medical University of Wroclaw, Wroclaw, Poland

2 Mayo Clinic and Foundation for Education and Research, Rochester, MN, USA

Address reprint requests to: I. Gosk-Bierska M.D., Ph.D., Clinic of Angiology, Hypertension and Diabetology, Medical University or Wroclaw, ul. Poniatowskiego 2, 50-326 Wroclaw, Polska. E-mail: [email protected]

Copyright Edizioni Minerva Medica Aug 2008

(c) 2008 International Angiology. Provided by ProQuest LLC. All rights Reserved.

Electrocardiographic Artifact Induced By an Electrical Stimulator Implanted for Management of Neurogenic Bladder

By Madias, John E

Abstract Serial electrocardiograms (ECGs) obtained in a 79-year- old woman revealed consistently sharp regular high-voltage spikes, which were superimposed on her ECG curve, and which were caused by an implanted pelvic electrical stimulator used for the management of a neurogenic bladder, with symptoms of urinary urgency and incontinence.

(c) 2008 Elsevier Inc. All rights reserved.

Keywords: Electrical stimulators; ECG; ECG artifacts; Neurogenic bladder; Neurostimulation

A recent contribution published in the Journal pertained to a patient whose electrocardiogram (ECG) showed in all the leads irregular “very sharp high-voltage spikes” at a cycle length of approximately 120 milliseconds, which were proven to be caused by an artifact engendered by the activation during the recording of the ECG of the enhanced pacemaker detection software of the electrocardiograph (MAC 5000, General Electric, Chicago, IL).

Case report

An ECG (Fig. 1A) submitted for routine interpretation showed a regular artifact consisting of sharp spikes of large amplitude, of approximately 25 milliseconds in cycle length, involving all the leads, but with attenuated amplitude of spikes in leads I and V2 to V6. The ECG had been obtained by an HP (now acquired by Philips) Page Writer XLi Model M1700A electrocardiograph, and showed probably sinus rhythm (although P waves are not discernible because of the artifact), with 2 premature atrial beats, at a mean rate of approximately 72 beats per minute, complete right bundle-branch block and left anterior fascicular block. An alternative diagnosis would be atrial fibrillation, with periods of “regularization.” Access to the patient’s ECG electronic file revealed 5 more ECGs, which were identical to the one in Fig. 1A; the rhythm varied in the other ECGs from regular, with or without premature atrial beats, without discernible P waves, but with 1 ECG showing an irregularly irregular rhythm. The printed report of the computer interpretation of these 6 ECGs was: “No analysis attempted for this ECG due to defective data,” and “artifacts are noted; repeat the ECG” (5 ECGs), and “No analysis attempted for this ECG due to defective data,” and “leads I, II, III, V1, V2, V3, V4, V5, V6 were not used for morphology analysis” (1 ECG). The spikes in the limb leads were exactly the same, whereas the ones in leads V1 to V6 varied somewhat in amplitude in different ECGs, apparently because of the variation in the placement of the ECG electrodes on the patient’s chest in recording the 6 ECGs. Whatever was producing this artifact had a 3- dimensional vectorial direction that was somewhat perpendicular on the axes of leads I, V2 to V6, particularly V3 and V4, thus producing a relatively low amplitude of the artifacts in leads V3 and V4. In contrast, the stability of the amplitude of the artifacts in the limb leads suggested that the source of the artifact had to have a fixed position and orientation relative to the patient’s body, and most probably was an implanted, than attached to the body, device. Extraneous electrical or magnetic sources for this artifact were ruled out from the beginning because all 6 ECGs showed an identical pattern of the artifact in the limb leads.

The ECGs were of a 79-year-old woman, admitted to the hospital after a fall, with trauma to her face and left shoulder. As per her medical record, she had hypertension, asthma, and a neurogenic bladder. The patient was on telemetry monitoring (HP, now acquired by Philips), and telemetry leads II and V2 revealed the same artifact and at the same cycle length, as in the standard ECG, with very low amplitude in V2 and barely perceptible in lead II (Fig. 1 B). Calibration signals to the left of the telemetry ECG strip revealed that the recording sensitivity was 1.0 mV less than 10.0 mm, but this undercalibration could not have been the only reason for the low amplitude of the artifacts in the telemetry ECG; most probably, the different orientation of the recording electrodes and the difference in filtering (filters “on” in the telemetry monitoring and frequency response for 0.50-150 Hz in the electrocardiograph) were the reasons for the less conspicuous representation of the artifacts in the telemetry recording. The patient’s medical records indicated that a device had been implanted in her pelvis for symptoms of neurogenic bladder. A previous radiograph of the pelvis from her radiology files revealed an implanted device (Fig. 2). Information from her urologist revealed that she had a “Medronics Interstim System for urinary control”2 implanted under the skin in the back of the right pelvis (Fig. 2) for symptoms of urinary retention, overactive bladder, urinary urgency, frequency, and incontinence. This constitutes an established therapy for neurogenic bladder, and a Web search disclosed an abundance of literature on the topic.3 This device- based neurostimulation therapy uses mild electrical stimulation of the second to fourth sacral nerves (the third in the case of this patient) that influences the behavior of the bladder, sphincter, and pelvic floor muscles to alleviate or eliminate symptoms. The battery of the type of the device this patient had implanted would be expected to last for approximately 9 years. In addition, the patient had been provided with a programmer (about the size of a cellphone), with an off/on switch of the implanted stimulator, and a modulator of the intensity of electrical stimulation. An ECG with the stimulator turned off could not be recorded because of the patient’s interim discharge from the hospital. Cardiologists, electrophysiologists, and electrocardiographers should be aware that ECG artifacts can be caused by a multitude of electrical and magnetic implanted or external noncardiac devices, which are being used at an accelerated rate for therapeutic stimulation of muscles, nerves, and other tissues and organs throughout the body.

Fig. 1. A, Standard ECG of the patient displaying superimposed artifacts. B, Telemetry leads II and V2 showing much less conspicuously the same superimposed artifacts.

Fig. 2. A portable anteroposterior frontal radiograph of the pelvis showing an electronic device (right) with leads projecting over the lower pelvis (left).

References

1. Kang JS, Simpson CS, Redfearn DP, et al. Enhanced pacemaker detection software-induced electrocardiographic artifact. J Electrocardiol 2008;41:6.

2. http://www.medtronic.com/physician/interstim/index.html (Accessed 22 February 2008).

3. Jezemik S, Craggs M, Grill WM, et al. Electrical stimulation for the treatment of bladder dysfunction: current status and fiiture possibilities. Neurol Res 2002;24:413.

John E. Madias, MD, FACC, FAHA*

Mount Sinai School of Medicine of the New York University and Division of Cardiology, EImhurst Hospital Center, New York, NY, USA

Received 16 February 2008

* Tel.: +1 718 334 5005; fax: +1 718 334 5990.

E-mail address: [email protected]

Copyright Elsevier Science Ltd. Sep/Oct 2008

(c) 2008 Journal of Electrocardiology. Provided by ProQuest LLC. All rights Reserved.

Autologous Intra-Arterial Infusion of Bone Marrow Mononuclear Cells in Patients With Critical Leg Ischemia

By Chochola, M Pytlik, R; Kobylka, P; Skalicka, L; Kideryova, L; Beran, S; Varejka, P; Jirat, S; Koivanek, J; Aschermann, M; Linhart, A

Aim. The injection of bone marrow mononuclear cells (BMMC) into the gastrocnemius muscle has given promising results in patients with critical limb ischemia (CLI). In this article, we have assessed whether a less invasive procedure, i.e. intravascular BMMC infusion, could be effective in this population of patients. Methods. A total of 28 limbs in 24 patients with CLI were treated. An amount of 276- 700 mL of marrow blood was harvested from posterior iliac crests and BMMC were obtained by standard procedure used for bone marrow transplantation. After performance of digital subtraction angiography, BMMC were injected laterally through a 4 Fr sheet. Primary outcome was efficacy of the procedure measured as heating of defects, frequency of high amputations and change of ischemia grade; among secondary outcomes were safety of the procedure, angiographic changes and changes in quality of life.

Results. One year after treatment, all patients were alive and only 2 patients have undergone high amputation. Eleven of 14 defects have healed (78%) and Fontaine grade of ischemia has changed from median grade 3.5 to median grade 2 (P

Conclusion. Intra-arterial infusion of BMMC can lead to significant and long-lasting subjective and objective improvements in patients with CLI. The results merit validation by randomized controlled studies in patients with less critical limb ischemia.

[Int Angiol 2008;27:281-90]

Key words: Extremities – Ischemia – Neovascularization, physiologic – Bone marrow – Quality of life.

The term chronic critical limb ischemia (CLI) has been used in patients with chronic ischemic pain necessitating a regular administration of analgesics for longer than 2 weeks, with cutaneous defects and distal necrosis due to proven obliterative artery disease and with a high probability of high limb amputation within 6- 12 months if the limb perfusion would not improve. Objective criteria include ankle blood pressures

The accurate incidence of CLI is not known. Worldwide, it is estimated to be about 0.5 million to 1 million new cases every year. The prognosis of patients with CLI is associated with high mortality and is comparable to patients with advanced malignant disease.3 While 5-year mortality of patients with ischemic leg disease with claudications is approximately 30%, in patients with CLI it is up to 50%.4 The principal causes of death in these patients are other cardiovascular diseases (myocardial infarction or stroke).5

This grave prognosis in patients with CLI has prompted the need for new therapeutic modalities, which would lead to limb salvage, a reduction of morbidity and mortality and improvement in their quality of life. The most successful therapeutic strategies are improvement of limb perfusion with surgical or percutaneous revascularization. However, patients with angiographic findings which does not permit either of these treatment modalities are the subjects of conservative treatment attempted at halting or slowing the progression of the disease, the improvement of local and general circulation, pain relief and on the healing of eventual defects. In approximately 20-30% of patients no treatment is effective and amputation is performed.

In preclinical experiments, administration of angiogenic precursor cells into the ischemic limb leads to improved perfusion and higher rate of limb salvage.6,7 Therefore, this method could become an alternative to the conservative treatment of patients with CLI. Several case reports and phase I-II clinical trials seemed to bring promising results with mononuclear bone marrow cells being mostly used as source of angiogenic precursors.8-10 However, the administration of these cells has been usually intramuscular, which could lead to the short-term aggravation of pain and potential risk of infection in these highly susceptible locations. Therefore, we have performed a feasibility and efficacy pilot study of intra- arterial infusion of bone marrow in patients with CLI who were either not eligible for surgical or percutaneous revascularization, refused it, or the revascularization attempt had failed.

Materials and methods

Patients eligibility

Patients 18-85 years old were eligible for the study if they had grade III or IV leg ischemia according to Fontaine classification, with or without defects and without possibility of surgical or transcutaneous revascularization. Patients had to be able to undergo a surgical procedure under general or epidural anesthesia and all the patients had signed informed consent according to Helsinki declaration. The study was approved by the local ethical committee.

Exclusion criteria were: critical stenosis of coronary artery or unstable angina pectoris; previous malignant disease treated with chemotherapy or pelvic radiotherapy; and other uncontrolled medical disorders. For purposes of the endothelial progenitor assay, the patients should have not undergone treatment with statins for the previous 1 month.

Pretreatment and post-treatment evaluation procedures

DIGITAL SUBTRACTION ANGIOGRAPHY

Digital subtraction angiography (DSA) was performed by retrograde puncture of the femoral artery in the involved leg. The site of the puncture was infiltrated with 10 mL of 1-2% Mesocain. For DSA, iodine contrast (Iomeron, Bracco, Germany) was applied through 4 Fr sheet with constant speed of 10 mL/min. Documentation was performed in at least 6 segments of the limb, with speed of 1-3 images/s, to document both the arterial and venous phase of angiography. DSA was performed as part of the evaluation procedures before and after implantation of marrow mononuclear cells and after 1 year. Evaluation of the development of collateral vessels was performed in a blinded fashion by two independent angiologists on a semiquantitative scale, where the worsening of angiography was scored as -1, no change as 0, slight improvement as 1 and significant improvement as 2. Evaluation was performed both on positive and negative images.

ANKLE-ARM INDEX MEASUREMENT

Ankle-arm index (AAI) was performed according to Rutherford et al.11 For measurements, an 8 MHz Doppler probe was used to localize the pulse signal at the posterior tibial artery or dorsalis pedis. The cuff was placed on the distal thigh of patients lying in the supine position. The measured pressure was compared with the pressure measured at the brachial artery. AAI measurements were performed before mononuclear cell implantation, after 6 and after 12 months.

TRANSCUTANEOUS OXYGEN PRESSURE MEASUREMENT

Transcutaneous oxygen pressure measurement (tcpO^sub 2^) was performed on the dorsum of the involved foot between 1st and 2nd metatarsal.12 This non-invasive method indirectly evaluates skin perfusion. This measurement was performed with Clark’s probe, working on polarographic principle and measuring the partial pressure of oxygen diffusing through skin. The TCM400 Mk2 (Radiometer Copenhagen, Copenhagen, Denmark) was used for all measurements.

QUALITY OF LIFE OUTCOMES

Quality of life (QoL) was prospectively measured with the SF-36 questionnaire. This is the most extensively utilized tool for QoL assessment, is not specific for any given disease and has been successfully used in many diseases, including cardiovascular diseases and ischemic leg disease. The questionnaire was filled in before cell implantation and at 1 year after the implantation. The questionnaire consists of 36 questions aggregated into 8 domains (1. Physical functioning; 2. Role-physical; 3. Role-emotional; 4. Social functioning; 5. Bodily pain; 6. Mental health; 7. Vitality; 8. General health), which then can be used for calculation of two composite scores (physical composite score [PCS] and mental composite score [MCS]). The questionnaire was evaluated according to appropriate instructions13 and physical and MCSs were calculated with the online NBS calculator (www.sf-36.org).

OTHER EXAMINATIONS

Ischemic defects in all patients were photo-documented before treatment and then at 6-month intervals. Usual preoperation blood tests, electrocardiogram (ECG), blood sugar and lipid measurement were performed before stem cell harvest. In the afternoon and on the day after harvest, ECG, blood count and set of cardiology enzymes to detect possible myocardial damage were performed. Treadmill exercises were not performed, because more than 50% of patients had either ischemic pain at rest or foot defects making the pretreatment test impossible.

Treatment

BONE MARROW MONONUCLEAR CELL HARVEST AND PROCESSING

Bone marrow cell harvest was performed under standard aseptic conditions under general or epidural anesthesia. Approximately 350- 400 mL of bone marrow blood in 3-4 mL portions was harvested from one or more skin punctures from one or both posterior iliac crests with standard single-use needle for bone marrow harvest (Somatex, Teltow, Germany). The marrow blood clotting was prevented with the normal saline-heparin solution. The marrow blood was collected in the Bone Marrow Collection Kit with Pre-Filter and Inline Filters (Baxter, Deerfield, IL, USA) which have indwelling filters for removal of large marrow particles. After the filtration of the blood from the collection bag to the transport and to the processing bag, the blood was transferred onto the Cell Therapy Unit of the Institute of Hematology and Blood Transfusion for further processing. The appropriate amount of Gelofusin (B. Braun, Melsungen, Germany) was added directly to the processing bag and repeated red cell sedimentation was performed according to the standard operational procedure for approximately 2 h. The supernatant plasma, containing mainly nuclear cells and only a minimum amount of erythrocytes, was segregated by plasma-extractor and centrifuged again. Clear plasma was then transferred back to the sedimentation bag and the process was repeated. Then, the resulting mononuclear cell fraction was resuspended in approximately 30 mL of autologous plasma and prepared for intra-arterial infusion on the same day. Neither autologous nor allogeneic red cell transfusions were given routinely and the volume balance was kept with crystalloid solutions. EVALUATION OF STEM CELL CONTENTT IN THE GRAFT AND OF CIRCULATING ENDOTHELIAL PRECURSOR CELLS

For stem cell content of the graft evaluation, CD34 measurements were performed according to accepted standards.14,15 Colony-forming units, granulocyte-macrophage (CFU-GM) and burstforming units, erythroid (BFU-E) cultivations were performed on MethoCult(TM) (StemCell Technologies, Vancouver, Canada) according to the recommendation of the manufacturer. Briefly, 2×10^sup 4^ bone marrow mononuclear cells (BMMC) after hydroxyethylstarch sedimentation was seeded in 1 mL of complete MethoCult(TM) media in 35 mm Petri dishes. Each experiment was run in triplicate. Before placing in the incubator, the 35 mm Petri dishes were placed in larger 100 mm dishes to decrease the possibility of contamination and to allow for keeping the humidity. CFU-GM and BFU-E were then counted under inverted microscope according to their typical morphology.

BONE MARROW MONONUCLEAR CELL IMPLANTATION

Approximately 4 h after stem cell harvest, DSA was performed. After DSA, mononuclear cells were infused intra-arterially via lateral access into a 4 Fr sheet in a rate 900 mL/hod. Control angiography was performed after cell implantation. The patient was then monitored in the Angiology Intensive Care Unit, where the sheet was removed and puncture site compressed. The patient was allowed to walk after 8 h. After control examinations, the patient was discharged the day after the procedure.

Follow-up

Patients were regularly followed every 6 months after the procedure or as needed. Trophical defects were treated according to institutional guidelines.

Definition of outcomes

The primary endpoint was efficacy of the procedure evaluated 1 year after treatment. Measured outcomes were a change of ischemia grade according to Fontaine classification, healing of trophic defects and frequency of treatment failures, defined as high amputation, major cardiovascular accident (stroke or myocardial infarction) and death from any cause. Minor surgery for removal of necrotic defects already present before treatment was not considered as treatment failure.

Secondary endpoints were safety of the procedure, improvements in collateral vessel development assessed on angiographie measurements, improvements in blood perfusion of the treated limb, assessed as AAI and tcpO^sub 2^ measurement, and improvement of quality of life outcomes.

Statistical analysis

For comparison of continuous variables, a Mann-Whitney U-test was used for comparison of two non-paired samples and a paired t-test for two paired samples. For comparison of multiple samples containing continuous variables, a Kruskal-Wallis version of ANOVA test was performed with post-test calculation for trend. Correlations were calculated with Spearman correlation coefficient. P

Results

Patient characteristics

From 1 September 2004 to 31 December 2006, we performed 28 autologous intra-arterial infusions of BMMC in 24 patients. Median age was 68 years (range: 26-85 years), 13 patients were males and 11 females. In 4 patients, two procedures were performed and BMMC were infused to both legs in 5-13 month intervals between the two procedures. According to the Fontaine classification, grade III ischemia was present in 14 legs and grade IV ischemia in 14 legs. Fourteen patients (50%) had ischemic defects. In 21 patients (88%), the cause of arterial obliteration was atherosclerosis, while thromboangiitis obliterans was diagnosed in 3 patients (12%). Other characteristics are shown in Table I.

Bone marrow harvest

Median 400 mL (range: 276-700 mL) of mixture of bone marrow blood and heparin in normal saline was obtained in 28 procedures. Median number of 64.3 x 10^sup 8^ BMMC were harvested (range: 13.2-131.1 x 10^sup 8^). After processing, median numher of 34.9×10^sup 6^ (range: 3.96-135.4×10^sup 6^) CD34+ cells, 873 CFU-GM (range: 174-3 489) and 551 (128-2 512) BFU-E was infused. Other details of bone marrow harvest are shown in Table II. Of the pretreatment characteristics, we have found significant negative correlation between age and number of CD34+ cells (r=-0.41; P=0.04) and between age and number of BFU-E (r=-0.44; P=0.03). Also, a lower number of infused CD34+ cells was found in patients with concomitant ischemic heart disease (median: 27×10^sup 6^ vs 53×10^sup 6^ without ischemic heart disease; P=0.019) and a lower percentage (but not lower total number) of CD34+ cells was noted in patients with hyperlipidemia (0.64% vs 0.77% in patients without hyperlipidemia; P=0.03).

Treatment outcomes

PRIMARY OUTCOMES

In 1 year post-treatment, all patients were alive. Two of them had undergone high amputation of the treated limb at 3 months after treatment, both of them having Fontaine stage IV disease at the entry of the study. There were no cerebrovascular accidents. No patient had undergone high amputation beyond 1 year. One patient had died 2 years after the study entry from unrelated cause (after femoral neck fracture). The 1-year event free survival is 92%. Three patients had undergone minor surgical procedures to remove the ischemie tissue which was already present before treatment. Otherwise, 11 of 14 defects had healed in 1 year (78%, Figure 1).

According to Fontaine classification, the grade of ischemia had improved from a median value 3.5 to median value 2 (P

SECONDARY OUTCOMES

Safety.-The procedure was extremely well tolerated. There was nonsignificant decrease in hemoglobin levels 24 h after bone marrow harvest with no aggravation in ischemic symptoms. No red cell transfusions had to be administered. Patients were discharged at a median of 1 day (range: 1-3 days) after procedure. Only one episode of grade II bleeding developed from the site of the harvest, which was controlled by compression.

Angiography results.-One year after stem cell infusion, the mean improvement of angiographic findings in the treated extremity was 0.732 points in the site of puncture, 0.652 points in leg, 0.692 points in knee, 1.13 points in the calf and 1.3 points in the foot, measured on a semiquantitative scale as described above. There was a significant trend towards higher scoring in distal parts of the extremity (P=0.0001 on repeated measures ANOVA, test for trends). These results are shown in Figure 2. Representative pictures of pretreatment and posttreatment angiography are shown in Figure 3. However, there were no significant correlations between improvement in any of the measured sites and number of BMMC1 CD34+ cells, CFU- GM or BFU-E, nor there were any correlations between angiographic results and other objective measures of leg ischemia (i.e., AAI and tcpO2). We were also unable to find any pretreatment characteristics correlating with the changes in the angiographie findings. The Fontaine score did not correlate with the score of any specific site. However, if the mean value was calculated for all angiographie changes in a given patient, there was a significant correlation both between this mean value and the pretreatment Fontaine score (r=- 0.41; P=0.048) and between the mean value and post-treatment Fontaine score (r=-0.43; P=0.038).

Ankle-arm index and transcutaneous oxygen pressure measurement.- Both AAI and tcpO^sub 2^ increased substantially 1 year after treatment (P

Quality of life.-After treatment, there was significant improvement in all 8 domains of the SF36 questionnaire when compared with the pretreatment values (P0.95; P

The apparent success of preclinical studies of stem-cell induced angiogenesis has prompted the rapid implementation of this research into clinical practice. As most of the preclinical research has been performed on ischemic heart disease models and some of these trials implied that not only the coronary vessels, but also myocardium, could be repaired with stem cells,16,17 several well-designed randomized trials of cellular treatment of myocardial infarction or chronic ischemic heart disease have been conducted. Today, when the results of these trials have become available, it is clear that despite of statistically significant improvement in various clinical or laboratory outcomes in most of the studies, the clinical benefit is only short-term or of uncertain significance.18-23

Given the fact that skeletal muscle is much more resistant to hypoxia than cardiac muscle, it is interesting that only a few randomized trials of cellular treatment of ischemic leg disease are presently available. It is even more surprising given the fact that results of all of the published pilot studies or case series have been very optimistic.80-10, 24-34 However, most of these trials enrolled only a small number of patients and a publication bias cannot be excluded.

Only two randomized studies have been published so far. Tateishi- Yuyama et al. enrolled 47 patients with CLI and 22 of them with bilateral leg ischemia were randomly injected with BMMC in one leg and peripheral blood-mononuclear cells in the other. After both 4 and 24 weeks, there was a significant improvement of the AAI, transcutaneous oxygen pressure and leg pain in legs injected with the bone marrow cells.8 More recently, Huang et al. randomized 28 diabetic patients with CLI to a “transplant” group, which have received treatment with G-CSF mobilized peripheral progenitor cells and to a control group who had received a conservative treatment.31 Three months after treatment, laser Doppler blood perfusion and AAI were significantly improved in the “transplant” group and more limb ulcers were healed (14 of 18 vs. 7 of 18; P=0.016). Otherwise, we have identified only three other studies published in English which accrued more than 20 patients, two of them exclusively treating patients with Buerger’s disease.32-34

We have treated 28 ischemic legs in 24 patients with intra- arterial infusion of BMMC and we have evaluated the results of treatment after 1 year. In other studies, intramuscular injections into gastrocnemius muscle were usually used, possibly because of concern that in limbs with occluded vessels, the angiogenic cells might not reach the periphery and the results were typically evaluated early (3-6 months) after treatment. We are aware of one case series which have used intraarterial infusion of G-CSF mobilized peripheral blood mononuclear cells with results similar to our own.35 However, we have preferred BMMC to G-CSF mobilized peripheral blood progenitor cells mainly because G-CSF treatment may induce hypercoagulable state by increasing levels of FVIII:C and thrombin,36 and its use was accompanied with aggravation of ischemic syndromes in patients with known coronary disease,37 a high risk of in-stent restenosis,38 and even with major arterial thromboses in patients without previously diagnosed atherosclerosis.39 In addition, BMMC differ in their content from the mobilized peripheral blood progenitor cells and even the CD34+ cells mobilized to peripheral circulation have a different quality. As we have found before that the granulocyte-monocytic colonies (CFU-GM), and especially erythroid burst colonies (BFU-E) produce angiogenic factors,40 we considered bone marrow blood as a more appropriate source of cells for cellular-induced vasculogenesis. The fact that we did not find any correlations between the graft content of CD34+ cells or colony forming cells and outcome in this study, is not surprising in view of the predominating opinion that injected mononuclear cells are rather vascular factors producing cells than endothelial precursors,41 and the cytokine and chemokine network needed to induce angiogenesis is extremely complex.

To our knowledge, this is the first study of cellinduced angiogenesis utilizing the complex quality of life assessment tool to study the treatment impact on this outcome. The SF-36 questionnaire had been used in a variety of diseases including ischemie leg disease and it has unequivocally shown that quality of life in these patients deteriorates with the grade of ischemia.42 It has also been shown that a successful revascularization procedure can improve quality of life in many of these patients.43,44 Therefore, it is extremely important that our treatment had been able to improve quality of life of patients, where further revascularization cannot be performed.

Conclusions

In conclusion, our study contributed to the growing evidence of the effectivity of cell-mediated angiogenic treatment in patients with peripheral arterial disease. It has also shown that the benefit of the treatment lasts beyond 3 or 6 months, which had not been adequately assessed in previous studies. As the tolerability of the procedure by these critically ill patients was excellent and no significant adverse events have occurred, we suggest it might be justified to perform controlled studies also in patients with less critical ischemia, i.e. in the stage of claudications.

Fundings.-This work has been sponsored exclusively with the grant from Ministry of Public Health, Czech Republic (IGA MZCR NR-8047/ 3).

Acknowledgements.-Special thanks to Thomas O’Hearn, II., for the language revision of the manuscript.

Received on March 6, 2007; accepted for publication on June 15, 2007.

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16. Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F et al. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci U S A 2001;98:10344-9.

17. Jackson KA, Majka SM, Wang H, Pocius J, Hartley CJ, Majesky MW et al. Regeneration of ischemic cardiac muscle and vascular endothelium by adult stem cells. J Clin Invest 2001;107:1395-402.

18. Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C et al. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet 2004;364:141-8.

19. Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T et al. Intracoronary injection of mononuclear bone marrow ceils in acute myocardial infarction. N Engl J Med 2006;355:1199-209. 20. Schachinger V, Erbs S, Elsasser A, Haberbosh W, Hambrecht R, Holschermann H et al, for the REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med 2006;355:1210-21.

21. Assmus B, Honold J, Schachinger V, Britten MB, Fischer- Rasokat U, Lehman R et al. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med 2006;355:1222-32.

22. Janssens S, Dubois C, Bogaert J, Theunissen, K, Deroose C, Desmet W et al. Autologous bone marrow-derived stemcell transfer in patients with ST-segment elevation myocardial infarction: double- blind, randomised controlled trial. Lancet 2006;367:113-21.

23. Meyer GP, Wollert KC, Lotz J, Steffens J, Lippolt P, Fichtner S et al. Intracoronary bone marrow cell transfer after myocardial infarction: eighteen months’ follow-up data from the randomized, controlled BOOST (Bone marrOw transfer to enhance ST-elevation infarct regeneration) trial. Circulation 2006;113:1287-94.

24. Higashi Y, Kimura M, Kara K, Noma K, Jitsuiki D, Nakagawa K et al. Autologous bone-marrow mononuclear cell implantation improves endothelium-dependent vasodilation in patients with limb ischemia. Circulation 2004;109:1215-8.

25. Miyamoto M, Yasutake M, Takano H, Takagi H, Takagi G, Mizuno H et al. Therapeutic angiogenesis by autologous bone marrow cell implantation for refractory chronic peripheral arterial disease using assessment of neovascularization by 99mTc-tetrofosmin (TF) perfusion scintigraphy. CeU Transplant 2004; 13:429-37.

26. Yamamoto K, Kondo T, Suzuki S, Izawa H, Kobayashi M, Emi N et al. Molecular evaluation of endothelial progenitor cells in patients with ischemic limbs: therapeutic effect by stem cell transplantation. Arterioscler Thromb Vasc Biol 2004;24:e192-6.

27. Ishida A, Ohya Y, Sakuda K, Ohshiro K, Higashiuesato Y, Nakaema M et al. Autologous peripheral blood mononuclear cell implantation for patients with peripheral arterial disease improves limb ischemia. Circ J 2005;69: 1260-5.

28. Nizankovski R, Petriczek T, Skotnicki A, Sczeklik A. The treatment of advanced chronic lower limb ischaemia with marrow stem cell autotransplantation. Kardiol Pol 2005;63:351-60.

29. Miyamoto K, Nishigami K, Nagaya N, Akutsu K, Chiku M, Kamei M et al. Unblinded pilot study of autologous transplantation of bone marrow mononuclear cells in patients with thromboangiitis obliterans. Circulation 2006;114:2679-84.

30. Hernandez P, Cortina L, Artaza H, Pol N, Lam LM, Dorticos E et al. Autologous bone-marrow mononuclear cell implantation in patients with severe lower limb ischaemia: a comparison of using blood cell separator and Ficoll density gradient centrifugation. Atherosclerosis 2006;DOI: 10.1016/j.atherosclerosis.2006.08.025

31. Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care 2005;28:2155-60.

32. Durdu S, Akar AR, Aral M, Sancak T, Eren NT, Ozyurda U. Autologous bone-marrow mononuclear cell implantation for patients with Rutherford grade II-III thromboangiitis obliterans. J Vasc Surg 2006;44:732-9.

33. Kim DI, Kim MJ, Joh JH, Shin SW, Do YS, Moon JY et al. Angiogenesis facilitated by autologous whole bone marrow stem cell transplantation for Buerger’s disease. Stem Cells 2006;24:1194-200.

34. Kawamura A, Horie T, Tsuda I, Abe Y, Yamada M, Egawa H et al. Clinical study of therapeutic angiogenesis by autologous peripheral blood stem cell (PBSC) transplantation in 92 patients with critically ischemic limbs. J Artif Organs 2006;9:226-33.

35. Lenk K, Adams V, Lurz P, Erbs S, Linke A, Gielen S et al. Therapeutical potential of blood-derived progenitor cells in patients with peripheral arterial occlusive disease and critical limb ischaemia. Eur Heart J 2005;26:1903-9.

36. LeBlanck R, Royi J, Demersi C, Vu L, Cantin G. A prospective study of G-CSF effects on hemostasis in allogeneic blood stem cell donors. Bone Marrow Transplant 1999;23:991-6.

37. Kang HJ, Kim HS, Zhang SY, Park KW, Cho HJ, Koo BK et al. Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: the MAGIC cell randomized clinical trial. Lancet 2004;363: 751-6.

38. Hill JM, Syed MA, Arai AE, Powell TM, Paul JD, Zalos G et al. Outcomes and risks of granulocyte colony-stimulating factor in patients with coronary artery disease. J Am Coll Cardiol 2005;46:1643-8.

39. Kawachi Y, Watanabe A, Uchida T, Yoschizawa K, Kurooka N, Setsu K. Acute arterial thrombosis due to platelet aggregation in a patient receiving granulocyte colony-stimulating factor. Br J Haematol 1996;94:413-6.

40. Pomyje J, Zivny J, Sefc L, Plasilova M, Pytlik R, Necas E. Expression of genes regulating angiogenesis in human circulating hematopoietic cord blood CD34+/CD133+ cells. Eur J Haematol 2003;70:143-50.

41. Heil M, Ziegelhoeffer T, Mees B, Schaper W, A different outlook on the role of bone marrow stem cells in vascular growth, bone marrow delivers software not hardware. Circ Res 2004;94:573-4.

42. Dumville JC, Lee AJ, Smith FB, Fowkes FGR. The health- related quality of life of people with peripheral arterial disease in the community: the Edinburgh Artery Study. Br J Gen Pract 2004;54:826-31.

43. Aquarius AE, Denollet J, Hamming JF, Breek JC, De Vries J. Impaired health status and invasive treatment in peripheral arterial disease: a prospective 1-year follow-up study. J Vasc Surg 2005;41:432-42.

44. Kalbaugh CA, Taylor SM, Blackhurst DW, Dellinger MB, Trent EA, Youkey JR. One-year prospective quality-of-life outcomes in patients treated with angioplasty for symptomatic peripheral arterial disease. J Vasc Surg 2006;44: 296-302.

M. CHOCHOLA1, R. PYTLIK 2, P. KOBYLKA 3, L. SKALICKA 1, L. KIDERYOVA 2,

S. BERAN 1, P. VAREJKA 1, S. JIRAT 1, J. KOIVANEK4, M. ASCHERMANN 1, A. LINHART 1

1 2nd Department of Medicine, Cardiology and Angiology, General University Hospital, Prague, Czech Republic

2 Laboratory of Experimental Cellular Therapy, 1st Department of Medicine-Hematooncology,

General University Hospital, Prague, Czech Republic

3 Institute of Hematology and Blood Transfusion, Prague, Czech Republic

4 Department of Radiology, General University Hospital, Prague, Czech Republic

Address reprint requests to: M. Chochola, 2nd Department of Medicine, Cardiology and Angiology, General University Hospital, U nemocnice 2, 128 08 Praha 2, Czech Republic.

E-mail [email protected]

Copyright Edizioni Minerva Medica Aug 2008

(c) 2008 International Angiology. Provided by ProQuest LLC. All rights Reserved.

Beauvoir and the Question of a Woman’s Point of View

By Mann, Bonnie

Recently, philosophers have taken to announcing a revival or a renaissance in the study of the philosophical work of Simone de Beauvoir.1 Sonia Kruks argues that feminist Beauvoir studies, having passed through an early ( 1970s) phase in which women related to Beauvoir as an icon, and through a middle (1980s) phase in which feminist thinkers related to Beauvoir as an adversary, has now entered a phase of serious philosophical engagement.2 This latter phase tends to be celebratory and corroborative, and is marked by “careful and creative unwindings and rewindings of Beauvoir’s arguments.”3 The new feminist work on Beauvoir is, to my mind with great success, in the process of repudiating a series of claims that were frequently stated with certainty during the age of antagonism: that Beauvoir was simply Sartre’s mouthpiece; that she in fact disparaged women and particularly loathed female bodies; that she was an essentialist; alternately that she was a radical constructivist with a voluntaristic notion of sexual difference; and that she unequivocally and unapologetically adopted a masculine point of view.4 The repudiation of these claims has required detailed attention to the now well-documented failures of the (still, though this is soon to change) only English translation of the text;5 careful studies of the many philosophical influences on Beauvoir’s work besides Sartre;6 studies that attempt to show, through engagement with Beauvoir’s autobiographical and literary works in relation to the philosophical works of both Beauvoir and Sartre, that she in fact influenced him;7 and attention to the originality of Beauvoir’s philosophical method and often parodie voice.8

When I teach Beauvoir, my students are quickly moved by the new scholarship to acknowledge that Beauvoir cannot be reduced to Sartre; that there is both compassion and passion for women in her account; that her Marxist-influenced existential phenomenology can neither be reduced to essentialism nor to constructivism. But they often remain convinced that Beauvoir is taking up a “masculine point of view,” and in fact advocating that other women, as well, adopt male values, projects, and perspectives.9 There is still a great deal of work to be done to show in sufficient textual detail that Beauvoir’s “point of view,” particularly in The second Sex, or rather the multiple points of view that help build this polyphonic and complex philosophical text, can in no way be sufficiently described as “masculine.” In fact such a description proves to be reductive in the extreme. A decidedly non-masculine point of view, one that is anti-masculinist, or feminist to put the matter more positively, emerges in the text itself, as a close reading of a particular moment of such emergence will show. As importantly, the opening toward such a point of view is perhaps the primary performative effect of the reader’s engagement with the text. This second claim, that the text does something to change the relationship of its readers to the masculinist world they are immersed in, is frequently mentioned but too little studied.10

It is my contention that Beauvoir keeps the promise that she makes at the end of the introduction to volume I of The second Sex, about what she will do in volume II. After showing us how women have been constituted as the Other from a man’s point of view, she pledges, “then from woman’s point of view I shall describe the world which is offered to them: and thus we shall be able to understand the difficulties they run up against, at the moment when, endeavoring to make their escape from the sphere hitherto assigned to them, they aspire to full membership in the human Mitsein.”11 Of course, the very notion that there can be something like a “woman’s point of view” is the source of some criticism of Beauvoir, while others criticize her for failing to achieve it. ’21 am more sympathetic with the first claim, those who make it note that Beauvoir’s women are white and European and educated for the most part, so that even if some women ‘s “point of view” emerges in the text, it certainly won’t be every woman’s point of view-which is not to say that it might not be worth engaging nevertheless, even if one doesn’t find oneself well-represented by it. Others are concerned that no women’s point of view emerges at all, not even a limited and privileged one.

Here, emphasizing a single moment of the emergence of a woman’s point of view, I will show that the latter have not read Beauvoir very well. I am referring to those who have argued that the point of view offered by Beauvoir does little but “reinforce the masculine view of sexual difference”;13 that she abandons “her ostensible goal of uncovering the specific point of view of women as other, adopting instead, for the most part, a masculine point of view”;14 that she urges women “to become to all intents and purposes like men,” by overcoming their immanence through “identifying with masculine ideals and aspirations”;15 that she “does little more than rehash and intensify perennial phallocratie bromides,” since she is, in the end, “trapped in a phallocentrism” which makes “her feminism nothing but the operation of a woman who aspires to be like a man and whose voice is that of the ventriloquist’s dummy.”16 As mentioned, I find such readings reductive in the extreme.

By calling these readings reductive rather than just wrong, I mean to acknowledge that Beauvoir does indeed inhabit, or at least attempts to inhabit, at least writes as if she inhabits, various masculine (or better, masculinist) points of view-why else cite literature and philosophy written about women by men so voluminously? She also moves into the points of view of many women, including women who are very different from her in situation and character-as is reflected in her voluminous citations of writings by women. It is her critical movement between, and into and out of points of view that characterizes Beauvoir’s innovative (and specifically feminist) philosophical method.

Beauvoir’s Method: “Certain Women,” Philosophy, and Everyday Life

Of all of those who have argued that Beauvoir fails to take up a woman’s point of view, Tina Chanter has done so most explicitly. Chanter’s own aspiration is to affirm the work of Luce Irigaray, and especially the ways that, on her view, Irigaray surpassed Beauvoir17 by daring to wonder “what stakes are at risk in affirming femininity,”18 or “what it might mean to envisage experience from a specifically feminine point of view.”19 Beauvoir’s work, was “circumscribed by a totalizing way of thinking,”20 i.e., a “Sartrian understanding of the self as a being which consists of nothing but freedom.”21 This dominant commitment made her misread Hegel’s master- slave dialectic, Chanter argues; she made “the role of the other structurally constant”22 instead of dynamic, and this caused her to lose the significance of her own insight that women are “other” to men.23 For Chanter, it is Irigaray, not Beauvoir, who has taken the otherness of women seriously enough to actually inhabit, think, and write from “a feminine point of view.”24

Chanter argues that Beauvoir’s philosophical failures in this regard cannot be divorced from her personal failure to cast her lot with women, or in other words to speak from inside women’s situation. “At times, Beauvoir approaches the situation of women as if it does not concern her personally. It is almost as if Beauvoir is a disinterested observer of other women, set apart from them.”25 Beauvoir “considered herself largely exempt from the problems normally associated with women,”26 and so writes “as if she has already, once and for all, overcome her otherness.”27 Indeed, Chanter cites Beauvoir’s own claim that “some of us have never had to sense in our femininity an inconvenience or an obstacle,”28 even as she appropriately mentions that Beauvoir eventually withdrew the statement that some women had “by and large . . . won the game.”29 Beauvoir cannot succeed in her project of telling the story of women from women’s point of view, Chanter believes, because “she steps out of the very situation she seeks to describe from within. She speaks about the situation of women from a privileged position, as a writer, as if it were a problem she encounters exclusively in others.”30

Yet there are other ways of reading Beauvoir’s self-positioning than as a simple affirmation of a masculinist point of view in relation to women.31 While Beauvoir’s contemporary readers are certainly correct to be suspicious of her claim to have escaped the disadvantages of her sex, especially given our own struggles to see Beauvoir’s work receive the recognition it deserves, to entertain such suspicions does not require us to dismiss Beauvoir’s own self- positioning as unequivocally masculine or masculinist. In fact, we can just as easily read her as suggesting that a capacity to move between points of view is necessary for the one who will carry out the project she has in mind (that of answering two questions: “What is a woman?” on the one hand, and Why are women, so intractably, in the position of other? on the other). We might also question her claim that “certain women,” women who are relatively privileged, even the skeptics among us might admit, are less affected by the oppression that other women suffer, and are necessarily the ones to carry out the project, without reading into such a view that these women are equivalent to men. After all, Beauvoir has already made it very clear that men are not qualified to undertake such a project.32 In the absence of an Angel, she argues the case for “certain women,” women like her, not because they live exclusively in a man’s world, but because they live in both or in between worlds. Still, we know the feminine world more intimately than do the men because we have our roots in it, we grasp more immediately what it means to a human being to be feminine; and we are more concerned with such knowledge. I have said that there are more essential problems, but this does not prevent us from seeing some importance in asking how the fact of being women will affect our lives. What opportunities precisely have been given us and what withheld? What fate awaits our younger sisters, and in what direction should they be guided?31

What would be the point of asking “what opportunities precisely have been given us, and what withheld” if one already knew for sure one were utterly unaffected by women’s situation? Here, Beauvoir poses this as a question to be explored, even as a few sentences before she already seemed to possess the answer. Yet many readers have been better at hearing the supposed answer than the question, which follows it and destabilizes it. Beauvoir’s method is characterized by the frequent stating of certainties, which are subsequently destabilized by questions or counter-examples, without necessarily being discarded altogether. Her readers are frequently bothered by this, as Penelope Deutscher notes in her defense of Beauvoir’s “notorious contradictions.” Deutscher’s carefully argued position is that we would do well to pay attention to “what those unstable elements enable in her work” rather than disregarding or trying to resolve them.34 My attempt here is precisely to pay attention to the “instabilities” in point of view that allow Beauvoir to facilitate the emergence of a feminist point of view for both herself and her readers.

Those readers, like Chanter, who are suspicious of Beauvoir’s contradictions, have tended not to explore carefully enough just how it is that Beauvoir is relating to and differentiating herself from the larger numbers of women who are not among the “certain women” who are qualified to write The second Sex. Chanter cites a passage from The Prime of Life in which Beauvoir gives her readers a kind of hint or foreshadow of her motivation for beginning The second Sex, mentioning a number of conversations with women “who led normal, married lives” that helped to convince her that a “specifically feminine ‘condition'” existed.35 These women were in different situations than Beauvoir’s usual women friends, who were educated and economically independent as she was. “Now, suddenly, I met a large number of women over forty who, in differing circumstances and with various degrees of success, had all undergone one identical experience: they had lived as ‘relative beings.'”36 Chanter uses this as further evidence that Beauvoir sees herself as removed from the “difficulties, deceptive advantages, traps, and manifold obstacles that most women encounter on their path,” and indeed, Beauvoir does say this was “a question which concerned me only indirectly.”37 But she also says, in a portion of the citation Chanter omits, “I didn’t yet attach a lot of importance to it.”38 The aspect of these varied women’s situations that is “identical” (though different from hers), their experience of having lived as relative beings, seems to be key for Beauvoir; it catches her attention.39 Indeed, she will come to attach a great deal of importance to it: what happens when one lives as a relative person, materially and ontologically dependent? These encounters are not dismissed as uninteresting conversations with slavish women, but taken account of as another step for Beauvoir in her move toward engaged philosophy. “I began to realize how much I had gone wrong before the war, on so many points, by sticking to abstractions. I now knew that it did make a very great difference whether one was a Jew or Aryan; but it had not yet dawned on me that such a thing as a specifically feminine ‘condition’ existed.”40 She has, to this point, seen the problem that she and her other women friends have encountered as “individual rather than generic.”41 Yet, here, she is moving away from such abstractions, by listening to women who have lived as “relative beings” and realizing that such relativity constitutes a specific, and specifically feminine, condition. Here she is being turned, through conversation, to a reconsideration of the abstract philosophy that cannot countenance such women and their lives-in fact the conversations affect how she sees her own life and the lives of those friends most like her. Chanter misses the spirit of self-criticism in this passage completely. Beauvoir suggests that she catches herself indulging in abstractions when her own troubles and those of her friends “in her eyes” are individual.42 She begins to realize that there is a “generic” element in their troubles; an element that she implies is related to the specifically feminine condition of living as a relative being.

Beauvoir encounters, through these new friendships, a point of view that is not hers but that will become important to her in her efforts to understand what it means to be a woman, even for those who have escaped the traditionally gendered condition of outright dependence. Again, Beauvoir is moving between points of view: this time that of the educated, economically independent woman who has access to and understands herself to be part of a world devoted to the life of the mind, a world which is, contingently but intransigently, masculine and masculinist; and that of women living women’s condition in more traditional ways.

The development in Beauvoir’s philosophical method that will allow her to write The second Sex is beginning here.43 Beauvoir’s own criticisms of her earlier philosophical work as “abstract” rather than sufficiently engaged with the concrete situations that constitute oppression and the limits of liberation, is just taking shape. As Bauer notes, “the great achievement of The Second Sex, to the extent that it succeeds as a work of philosophy, lies in Beauvoir’s finding a nonabstract and yet recognizably philosophical mode of self-conscious expression.”44 In what does this method consist?: “Beauvoir’s holding her everyday experience as a woman, in all its concreteness, in the same space as her philosophical investigation into what it means to be a woman, in all its abstraction.”45 Bringing philosophical abstraction into conversation with everyday experience (and we should note that it is not only her own everyday experience, but that of other women as well) is no easy task for a philosopher trained in abstractions, but Beauvoir manages it precisely through her agile movement between points of view, and because she refuses to divorce herself from the concrete and particular condition of being a woman, even as she notices that she has not lived the consequences of that condition to the same degree that other women have.

Beauvoir’s new philosophical method requires her to make room in her text for many voices to speak from many points of view,46 and it requires her to move into and dwell in those points of view for a time. Bringing philosophy into conversation with everyday life requires listening to what is commonly said about women, also by those quoting Plato, Aristotle, and other great men; those who effectively help to constitute the “metaphysical-imaginary level”47 of women’s situation of oppression. It requires listening to and inhabiting the points of view of women and girls as well, whose lived experience both varies and overlaps; as Beauvoir does so effectively through her voluminous citations of women’s diaries, women psychoanalysts, a broad array of women writers, and her own conversations with women. These points of view are entangled, they are in conversation with one another, they interrupt, contradict, and corroborate one another, with a complexity that is, at times, utterly overwhelming. The cacophony exposes the contingency and situatedness of each point of view in relation to the others, without sacrificing the ethical force of the claim for freedom for women that begins to emerge in the process.

Beauvoir’s Four Worlds: Woman’s Situation and Character

A particular moment of The second Sex in which the question of “point of view” is worked out in great detail occurs late in volume 2, in the chapter entitled “Situation and Character of Woman.” Yet this chapter has received very little critical attention, including by Chanter, who doesn’t mention the chapter in her own essay taking Beauvoir to task for not fulfilling her promise to speak of women from “women’s point of view.” To be clear, the entire second volume is replete with women’s points of view, and I find it almost impossible to understand how Chanter makes her claim without at the same time engaging the many women’s voices Beauvoir engages; one would need to at least make an argument that the presence of these women’s voices does not express or represent Beauvoir’s own point of view in any meaningful way, and that she included them for some other reason. The point I would like to make here is a slightly different one, however, because in “Situation and Character” Beauvoir leaves off her practice of lengthy, polyphonic citations, and promises, “we will try to adopt a synthetic view.”48

The “synthetic view” Beauvoir proposes will, in part, be one that simply confirms her constant claim that situation gives rise to character. All of the multiple, contradictory, disparaging, and paternalistically glorifying things that are said of women, and that women themselves expose when they speak, are not simply false, but contain elements of truth. The “truth” of these elements points, however, not to women’s biology or “the structure of the female brain,” but to characteristics that “are shaped as in a mold by her situation.”49 Beauvoir refuses to glorify the oppression of women or to flatter women by turning “her prison into a heaven of glory, her servitude into sovereign liberty.”50 She doesn’t exalt the “eternal feminine” because to do so is a “sometimes ridiculous, often pathetic”51 attempt to turn one’s subordination into virtue; a tendency she will soon examine in detail through the characters of the narcissist, the woman in love, and the mystic. Oppression, on Beauvoir’s view, rarely makes virtuous heroes. But this chapter, in fact, does much more work than that. In drawing her conclusions about the relation between situation and character for both men and women, Beauvoir, in great detail, gives an account of four points of view which emerge from the situations in which both men and women find themselves. In the end, we will find women judging men and the masculine universe, and often not in positive terms. Men are frivolous and obtrusive drone bees, children, simpletons, tyrants, and egoists.52 Beauvoir herself moves between points of view, inhabiting and articulating their truths and their judgments, destabilizing all of them in the process. But she also draws some very important conclusions about women’s points of view and their relation to the truth, conclusions that make the claim that Beauvoir herself took up and affirmed or celebrated a masculinist point of view in some simple way clearly untenable.

As she moves between points of view, sometimes several times in a single sentence, she constructs an elaborate account of what I am calling for the sake of conceptual clarity, four distinct, interdependent, conflicted, and complex worlds. We might simply say that Beauvoir shows us the world from four distinct, interdependent, conflicted and complex points of view; but in fact the separate points of view in question constitute worlds of value that are distinct and identifiable. Beauvoir’s descriptions of each world allow us to identify an ontology, epistemology, temporality, and mode of relation particular to it.

Beauvoir begins her account by noting, echoing her claim in the introduction that women “live dispersed among the males,”53 that women don’t have an independent society, but live as subordinates “integrated into the collectivity governed by the males,”54 unable to constitute a truly revolutionary collectivity themselves. Yet women have a world, enclosed, surrounded as it is by the “masculine universe,” a world which they set up “within the frame of the masculine universe.”55 “Hence the paradox of their situation: they belong at one and the same time to the male world and to a sphere in which that world is challenged”;56 a circumstance which creates a certain tension that deeply characterizes women’s situation and women’s points of view.

The dominant masculine universe is, as to be expected by now, the universe of transcendence and action, of projects and world-making. The dominant feminine world is the world of immanence and repetition, of drudgery and jam-making. Yet this fundamental division, which has been clearly specified in the text from the beginning, is given new detail and clarity at this moment in the text. In addition, the outlines of two other worlds begin to emerge, because of course the masculine world requires the feminine and vice versa, so that there is a relation and a movement between them. As it turns out, there is a feminine relation to the masculine world of transcendence that constitutes a world of its own, and a masculine relation to the world of immanence that constitutes its own world as well. I will discuss each in turn, referring to the four worlds under the following designations: the masculine world of transcendence; the feminine world of immanence; the masculine world of immanence; and the feminine world of transcendence. In addition, there is a feminine relation to both masculine points of view which, while not constituting a world in itself, allows a woman’s point of view to emerge in an extremely sharp and critical way.

The Masculine World of Transcendence

The masculine world of transcendence is the world that Beauvoir’s detractors accuse her of uncritically affirming. This is the world of projects, risk, and action, understood by the men who are at home there to be governed by the universal laws of nature and reason.57 In this world, technical training permits the domination of matter, and its typical inhabitant is accustomed to approaching his world as “an assemblage of instruments” intermediate between his will and his goals.58 Here an ontology of mechanical causality is accompanied by an epistemology of science and reason. The individual’s mode of relation to his world is one of knowledge/action, at an extreme, of conquest. “He regards history as a becoming,”59 because in this world, the future is open and progress, while not assumed, is expected. A temporality of progress requires both continuity and creativity in relation to the past. Man is the creative element that shapes time into progress.

In this world, action is a teacher, and the one who does also learns. “Her husband, her son, when undertaking an enterprise or facing an emergency, run their own risks; their plans, the regulations they follow, indicate a road through obscurity.”60 The lessons of action tend to moderate extreme views of right and wrong, “the individual who acts considers himself, like others, responsible for both evil and good, he knows that it is for him to define ends, to bring them to success; he becomes aware, in action, of the ambiguousness of all solutions; justice and injustice, gains and losses, are inextricably mixed.”61 The man of transcendence has a grasp upon the world, confidence in the complex efficacy of his action, and above all a sense of himself as one who creates value. His actions will participate in the course of history and the shaping of our collective public life.

The Feminine World of Immanence

The world of immanence, centered in the private sphere of the household, is where woman enjoys “a precarious sovereignty.”62 “Precarious” because her power depends on her accommodation to and ability to “listen” to the magic forces that govern this realm.63 “It is not matter she comes to grips with but life; and life cannot be mastered through the use of tools: one can only submit to its secret laws.”64 In the home, she is a patient alchemist: “One must obey the fire, the water, wait for the sugar to melt, wait for the dough to rise, and also for the wash to dry, for the fruits to ripen.”65 This world is not under her control, “it is, on the contrary, something obstinately resistant, unconquerable; it is dominated by fatality and shot through with mysterious caprices.”66 An ontology of magic is attended by an epistemology of hidden forces, “the continuity of which can be accepted without being understood.”67 In pregnancy and childbirth, she “feels the strength of a continuity that the most ingenious instruments are unable to divide or to multiply.”68 Her mode of relation to her world is one of harmony, not conquest; she works with the hidden forces, not against them; except insofar as such forces threaten decay. In this world, time is repetition, at its worst “a slow deterioration: it wears out the furniture and clothes as it ruins the face”;69 and “women’s fate is bound up with that of perishable things”;70 this temporality of repetition and decay applies to women as well. Housework, repetitious in itself, is the activity through which a woman stakes a hopeless claim against the ravages of time. Yet this world does not leave her entirely powerless. “The domain in which she is confined is surrounded by the masculine universe, but it is haunted by obscure forces of which men are themselves the playthings; if she allies herself with these magical forces she will come to power in her turn.”71

Beauvoir is herself ambivalent about women’s tendency to embrace the magical world of nature as a way of lending it “a transcendent dimension.”72 She affirms that a relation to the natural world teaches that “life is not merely immanence and repetition; it has also a dazzling face of light; in flowery meadows it is revealed as Beauty.”71 Wandering in nature is a free activity, often engaged in by young girls, to which the adult woman sometimes returns. “Any woman who has preserved her independence through all her servitudes will ardently love her own freedom in nature,”74 Beauvoir asserts, “it is ecstasy to find herself alone on the hillsides; she is no longer mother, wife, housekeeper, but a human being; she contemplates the passive world, and she remembers that she is a wholly conscious being, an irreducible free individual.”75 Here women move through the world of immanence to a sense of themselves as something more than “relative beings.” Yet Beauvoir is critical of the elements of superstition that help to structure women’s point of view in this realm. “Her attitude will be one of conjuration and prayer,” Beauvoir notes, “to obtain a certain result, she will perform certain well-tested rites.” This leaves women “ignorant of what constitutes true action, capable of changing the face of the world.”76 As we know, for Beauvoir, freedom itself is world- changing, value-creating action-if women encounter freedom and their own humanity wandering in nature, that freedom can only be fulfilled in “true action” which requires the presence of other freedoms and has meaning only in relation to them.

Nevertheless, as we will see in more detail below, women’s relation to the realm of immanence constitutes a point of view which enables her to gain critical distance, at least sometimes, from the masculine. “Masculine reasoning is quite inadequate to the reality with which she deals,” Beauvoir notes. Even as “in the world of men, her thought, not flowing into any project, since she does nothing, is indistinguishable from daydreaming,”77 in her world “the male seems light,” like one whose power is real but abstract;78 this is a power that demands things but can’t manage to accomplish anything on its own. The Masculine World of Immanence

Critics of The second Sex often accuse Beauvoir of simply reaffirming a division between either nature and culture, or immanence and transcendence, or both. They read her as having uncritically opposed the two realms.79 What is missing from these accounts is that Beauvoir saw the two realms as having an ambiguous rather than oppositional or simple hierarchical relation to one another. A relation of ambiguity, for Beauvoir, while containing moments of opposition and tension, is not reducible to a simple opposition; it includes dependencies, harmonies, inversions, and limits as well. While Beauvoir clearly associates men with transcendence and women with immanence throughout The second Sex, and clearly believes that women’s association with the realm of immanence is a primary structure of women’s oppression, to describe the relation between immanence and transcendence as one of simple opposition and hierarchy (the realm of immanence being the inferior) misses the fact that one of Beauvoir’s chief criticisms of idealism in the history of Western philosophy was that it constituted a flight from immanence.80 Immanence, for Beauvoir, is not to be overcome, but taken up; escape or flight is as inauthentic as is escape or flight from freedom.

No wonder, then, that we find men do live in the world of immanence, for Beauvoir, and not very well. In “Situation and Character” we find that “there is a whole region of human experience which the male deliberately chooses to ignore because he fails to think it.”81 This is why the housekeeper can exclaim in frustration, “Men, they don’t think!”82 Yet, men do cross the threshold into the domain of immanence daily. Perhaps the primary loss suffered by men at the moment of this crossing is the loss of masculine logic. “A syllogism is no help in making a successful mayonnaise, nor in quieting a child in tears, masculine reasoning is quite inadequate to the reality with which [woman] deals.”83 In fact, the “masculine apparatus loses its powers on the frontier of the feminine realm,”84 “the weapons of thought are shattered.”85 The ontology of reason and mechanical causality that secures his power in the world of transcendence must be left on the doorstep, as it were, it won’t work here.

A man’s response is determined disinterest in how things work, as long as they do, and on command. “The engineer, so precise when he is laying out his diagrams, behaves at home like a minor god: a word, and behold, his meal is served, his shirts starched, his children quieted; procreation is an act as swift as the wave of Moses’ wand, he sees nothing astounding in these miracles.”86 Nothing astounding, because a god need not be astounded at his power to work miracles through divine command. When he steps over the threshold into the realm of immanence, a man enters an ontology of the miraculous. His epistemology, if he has one, is that a god might have; the only thing the “paternal minor god” needs is to know is that his commands bring forth miracles, that both matter and creatures obey him. His mode of relation to the world he enters, then, is one of divine command. Time changes when he walks through the door. It is no longer time in the shape of progress, but rather the temporality of instantaneous creation that he experiences. “The concept of the miracle,” Beauvoir notes, “is different from the idea of magic: it presents, in the midst of a world of rational causation, the radical discontinuity of an event without cause…. The newborn child is miraculous for the paternal minor god, magical for the mother who has experienced its coming to term within her womb.”87 The mother who carries the child and births her into separate existence is party to the hidden forces of life, while the father merely receives the miraculous gift, one he considers to be of his own creation. “He has the lightness of dictators, generals, judges, bureaucrats, codes of law, and abstract principles;” from the point of view of those who know the mysterious forces of life he seems frivolous and obtrusive.88

Of course a minor god such as this, comfortable with divine command, will be utterly awkward, laughable even, if he steps down from his throne and actually tries to do something rather than command that it be done. Women know this, and are sharply cynical in relation to men’s power in this realm, “she sees man from top to toe, as a valet sees his master”; 89 she knows that he is incompetent and dependent on her in the realm of immanence, that without her his power is mere abstraction. In this world, she is not a religious woman but a mystic, and her husband’s divine command breeds cynicism, resentment, protest, complaint, even cruelty, in response. This is not to say, however, that she is not a religious woman at all, she becomes so, at least for a time, in relation to the world of transcendence.

The Feminine World of Transcendence

While the feminine relation to transcendence is tenuous, on Beauvoir’s view, it still manages to constitute a world with a distinct ontology, epistemology, temporality and mode of relation from the others. Lacking in “the technological training that would permit her to dominate matter,”90 “ignorant of what constitutes true action, capable of changing the face of the world,” and “not familiar with the use of masculine logic,”9I this world seems to her to be opaque. In relation to this realm, her husband is “the liberating hero, the divinity who bestows values”;92 she gains her worth in this realm, and what access she has to it, through her relation to him. Beauvoir takes note of the ecstatic expression “He’s a man!” as an example of the awe that some women are only too eager to express in the face of masculine virility93-another version of the expression is “He’s a man’s man!” I was reminded of the exclamation I’ve heard from parents about their male children, “He’s all boy!” meant to invoke lighthearted frustration undergirded by awe and pride. These exclamations seem, simultaneously, to confer value on the girlfriend or wife, on the mother who uses them. He has access, even more than less manly men, to the realm of action and meaning in which things are done and values count in the most public, collective sense. This realm is not opaque, but completely transparent to him. Here, her value is also established-by her connection to him.

Given this situation, she has little recourse but to adopt a mode of relation to this world that resembles religious commitment. “The masculine world seems to her a transcendent reality, an absolute,” so that for her, the ontology of this world is mysterious in the way that a divinity or an absolute is mysterious to the world of mortals. Her epistemology is dogmatic faith, “blind, impassioned, obstinate, stupid.” w She is dependent, for her own grasp upon the world, on her husband, who “embodies the masculine universe”95 and is situated so as to be able to act in it. The future is, for her, closed; she has no grasp upon this world that would give her hope of changing it except through him. She waits for change rather than undertaking it. A temporality of waiting and worrying is her lot.96

But this situation of dependence is unstable. It provokes, in women, a state of ecstatic awe and worshipful enthusiasm, on the one hand; but her enforced passivity provokes resignation on the other. And resignation is itself unstable. In fact, Beauvoir notes, “resentment is the reverse side of dependence.”97 A woman’s faith in the world of transcendence is liable to reverse itself and become persistent distrust. A free existent, cut off from the possibility of free action, is “not resigned to being resigned,” she is bound to protest the fact that “everything happens to her through the agency of others.”98 The instability of her situation of being a “relative being” in the realm of transcendence pushes toward the emergence of her own point of view.

Situational Instabilities and Women’s Points of View

A women’s point of view emerges in both the feminine realms of immanence and transcendence, as we’ve already seen. There are certain instabilities in her relation to men’s points of view that serve to motivate and sharpen this emergence even further. There are two aspects of this instability that I would like to examine more closely here: hypocrisy and lying. Women encounter masculine hypocrisy by observing how men move between the realm of transcendence and the realm of immanence, how they change, how they divest themselves of public values and commitments at the door to the private sphere. The masculine demand for lying on the part of women also serves to expose masculine dependence, vulnerability, and frivolity.

As women’s point of view emerges in the realm of immanence, Beauvoir notes that “to the myth of the praying mantis, women contrast the symbol of the frivolous and obtrusive drone bee.”99 He is frivolous and obtrusive from her point of view, because he fails to think the realm of immanence, or to understand how anything happens here. Nevertheless, he is fond of asserting the wisdom that reigns in the masculine realm of transcendence in conversation with her, because he needs her recognition. This she cannot give without reservation, since her point of view makes her see things differently, the world she is most at home in contests the world he presents to her. “It is understandable, in this [her] perspective, that woman takes exception to his masculine logic. Not only is it inapplicable to her experience, but in his hands, as she knows, masculine reasoning becomes an underhand form of violence; men’s peremptory proclamations are destined to mystify her.”100 She responds by sidestepping the argument rather than conceding; “halfway between revolt and slavery, she resigns herself reluctantly to masculine authority,” yet “she knows that he has himself chosen the premises on which his rigorous deductions depend.”101 In other words, she knows that the principles of his argument are not universal principles, even as he presents them as such. How does she know this? Because he doesn’t understand the first thing about how her world works, and she knows he doesn’t. “He will not convince her, for she senses his arbitrariness.”102 She understands that his is, in other words, another point of view, rather than god’s truth. Not only that, his point of view is interested, it is a way of winning power. “She refuses to play the game because she knows the dice are loaded.”103 He senses that he is not really winning. Really winning would mean that she would recognize his point of view as absolute, yet she only acquiesces to avoid an argument; he senses that she senses his frivolity, his arbitrariness.

Her skepticism of him is not only based on the differences between the feminine world of immanence and the masculine world of transcendence, however. What turns her suspicion into muted anger is her recognition that masculine morality “is a vast hoax,” and that her husband needs her to lie.

It is not only the changing nature of life that makes her suspicious of the principle of constant identity, nor is it the magic phenomena with which she is surrounded that destroy the notion of causality. It is as the heart of the masculine world itself, it is in herself as belonging to this world that she comes upon the ambiguity of all principle, of all value, of everything that exists. She knows that masculine morality, as it concerns her, is a vast hoax. Man pompously thunders forth his code of virtue and honor; but in secret he invites her to disobey it, and he even counts on this disobedience; without it, all that splendid facade behind which he takes cover would collapse.104

How does he “invite her to disobey”? In truth, this isn’t just an invitation, but a requirement. “Man even demands play-acting: he wants her to be the Other, but all existents remain subjects, try as they will to deny themselves. Man wants woman to be object: she makes herself object; at the very moment when she does that, she is exercising a free activity.”105 The duplicity required of her is not one that can always be successfully masked. “Sometimes the fact that in giving herself to him she looks at him and judges him is enough to make him feel duped; she is supposed to be only something offered, no more than prey. He also demands, however, that this ‘thing’ give herself over to him of her own free will: in bed he asks her to feel pleasure; in the home she must sincerely recognize his superiority and his merits.”106 His need for her recognition is unstable in that it requires a free subject, yet requires this free subject to make herself object, in which making she proves herself to be a subject-he demands, in short, that she “feign independence at the moment of obedience.”107 Should women succeed in somehow convincing their men of their adulation, afterwards, “with lovers or woman friends, they make fun of the naive vanity of their dupes.”108

Meanwhile, women recognize that the lying man demands of woman means that “his relations with woman lie .in a contingent region, where morality no longer applies, where conduct is a matter of indifference.”109 This situation destabilizes masculine morality in general. She sees, from her point of view, “the contrast between the lofty tone of his public utterances and behavior and ‘his persevering inventions in the dark.'”110

Men’s hypocrisy, their insistence that women lie, insure that women will recognize “that there is not any fixed truth,”1” even as men continue to demand that women recognize the “truth” they pronounce as absolute. Beauvoir is basically claiming here that women’s situation, their point of view in relation to what men say they know, pushes women to recognize a primary tenet of existentialist philosophy: that meaning and values are made, and must constantly be remade. Men’s “truths” are held in place by force. This realization is at the root of women’s “incoherent violence,”112 their attitudes of “constant reproach” of “complaint,”113 their “impotent revolt,”114 their “state of impotent rage.”115 Her husband (Beauvoir implies: not quite justly) is the object of her rage because “he embodies the masculine universe, through him male society has taken charge of her and swindled her.”116 While she does not have the kind of grasp upon the world that can enable her to establish a “solid counter-universe”117 to his, that would enable her to act collectively to change her situation,118 her rage must be interpreted as the only available “form of protest.”119

Conclusion

One does not protest without a point of view. Beauvoir’s own attitude toward such protest is clearly one of understanding, affirmation even, as she insists, “there are many aspects of feminine behavior that should be interpreted as forms of protest,” rather than character flaws.120 While there is nothing ideal about “impotent rage” it is a far cry from slavish complaisance. The one who affirms this rage as protest, who sees and invites her readers to see male hypocrisy and moral duplicity with and through the eyes of women in traditionally feminine situations, is far from unequivocally affirming a masculine point of view as either universal or normative. She translates impotent rage into ethical action. Beauvoir is, after all, protesting throughout The second Sex; protesting the situation of woman, the “feminine condition” that loosens a woman’s grasp upon the world, closes the future to her, and makes her live as a “relative being.”

But in the end, Beauvoir’s own point of view is not the same as that of the women who are living the “feminine condition” in its traditional form, who are living as “relative beings.” What makes “certain women” qualified to write a book like The second Sex is a capacity to move in and between points of view. This capacity itself emerges as a result of a situation: that of being a woman who has not suffered the lot of women to the extent that others have; that of being a woman who has had many of the privileges and opportunities that men traditionally enjoy; that of being a woman who has moved between worlds and retains her footing in more than one place at a time; that of being what, from a masculinist point of view, is a contradiction in terms: a woman who is also a philosopher and a writer. What makes “certain women” qualified to write about women from a woman’s point of view is being able to hear what a man couldn’t: the voice of another woman who experiences “the feminine condition” more acutely. It is a capacity to acknowledge that such a woman may be “more attentive than man” to herself and to the world,121 that she may experience time more intimately than man, that “she experiences more passionately, more movingly, the reality in which she is submerged than does the individual absorbed in an ambition or a profession,” that “she sometimes draws up real generosity,” and her suspicion of “ready-made forms and cliches is nearer to authenticity than is the self-important assurance of her husband.”122

Beauvoir thought that she needed economic independence, to start with, in order to be able to write The second Sex. She also needed another sort of independence, one that came from the experience of moving between worlds that had been traditionally closed to one another. This was an experience that loosened the holds of sanctified masculine truths, even as it gave her access to them; that kept her listening to the experiences of women more trapped within the “feminine condition” even as it gave her powerful intellectual tools to articulate the realities of that condition. To reduce Beauvoir’s ability to live and think the possibilities of her own situation, to construct a point of view through engaging many points of view, to a “male point of view” is to miss the point of what Beauvoir has done for us completely.

It is often noted that the act of reading The Second Sex has been life-changing for many women. I include myself here, since reading the book at the age of nineteen was what gathered my “impotent rage” into a feminist life. Reading the book still makes women into feminists: I see this every time I teach the text. The act of reading The second Sex can only do this because the book draws the reader into a point of view that is critical and anti-masculinist. It does this work by taking the reader on a 1000-page journey (700 if she is reading the English version!) into and out of a multitude of points of view, both masculine and feminine, on the subject of woman. These are interrogated, destabilized, questioned, contradicted; and gradually, a point of view that is ethically committed to the freedom of women emerges as a result. This is Beauvoir’s point of view, neither masculinist, nor traditionally feminine, bat feminist.

University of Oregon, Eugene, OR 97403-1295

ENDNOTES

1. Nancy Bauer, Simone de Beauvoir, Philosophy, and Feminism (New York: Columbia University Press, 2001); William McBride, “Philosophy, Literature, and Everyday Life in The Second Sex: The Current Beauvoir Revival,” Bulletin de la Societe Americaine de Philosophie de Langue Francaise 13 (2003): 32-44; Sonia Kruks. “Beauvoir’s Time/Our Time: The Renaissance in Simone de Beauvoir Studies.” Feminist Studies 31 (2005): 286-309.

2. Ibid. Kruks herself acknowledges that “the story is not quite as neat as I have suggested; stories never are” (289-90). During the adversary period, there were moments of engagement, and during the period of engagement, there are moments of dismissal that persist, as we will see below. 3. Ibid.

4. There are now many summaries of these claims. See for example: Penelope Deutscher, “The Notorious Contradictions of Simone de Beauvoir,” in Yielding Gender: Feminism, Deconstruction and the History of Philosophy (New York: Routledge, 1997); Bauer, Simone de Beauvoir, 3-4; Kruks “Beauvoir’s Time/ Our Time,” 287-89.

5. Margaret Simons. “The Silencing of Simone de Beauvoir: Guess What’s Missing from The Second Sex.” Women’s Studies International Forum 6/5 (1983): 559-64; Toril Moi. “While We Wait: Notes on the English Translation of The Second Sex.” in The Legacy of Simone de Beauvoir, ed. Emily R. Grosholz (New York: Oxford University Press, 2004), 37-68. Apparently, a new translation is now in the works, though the publishers have elected not to do a scholarly edition and the translators are not themselves philosophers. See “Bookforum” in Artforum, Apr/May 2007. It is important to note that the criticisms of Beauvoir mentioned here were by no means limited to readings of Beauvoir by English language speakers, however. While attention to the problems of translation have been key to troubling some work in the Anglo-American tradition of Beauvoir scholarship, and translation errors clearly exacerbated certain tendencies among Beauvoir’s English-language critics, better translation is not in itself enough to refute the main claims of the critics altogether.

6. See for example: Sara Heinamaa, Toward a Phenomenology of Sexual Difference: Husserl, Merleau-Ponty, Beauvoir (Lanham, MD: Rowman and Littlefield, 2003); Bauer, Simone de Beauvoir; Sonia Kruks, Situation and Human Existence: Freedom, Subjectivity and Society (London: Unwin Hyman, 1990).

7. See for example Kate Fullbrook and Edward Fullbrook, “Sartre’s secret Key,” in Feminist Interpretations of Simone de Beauvoir ed. Margaret A. Simons (University Park: Pennsylvania University Press, 1995), 97-111; Sonia Kruks, “Simone de Beauvoir: Teaching Sartre about Freedom,” in ibid., 79-95.

8. See Nancy Bauer, “Must we Read Simone de Beauvoir,” in The Legacy of Simone de Beauvoir, 115-35, for one of the best accounts of what Beauvoir manages, methodologically, in The second Sex, and Deutscher “The Notorious Contradictions,” for a positive account of the instabilities in Beauvoir’s text.

9. Fredrika Scarth argues that “the charges of masculinism . . . have come to constitute almost a critical consensus on The Second Sex” in “Simone de Beauvoir: A Masculine Mother?” in The Other Within: Ethics, Politics and The Body in Simone de Beauvoir (Lanham, MD: Rowman and Littlefield, 2004), 32. She, along with others (see also Bauer, Simone de Beauvoir), makes some headway in refuting this claim, yet it seems to persist in readers of Beauvoir in spite of these efforts. Scarth’s defense, with which I am in sympathy, is focused on accusations that Beauvoir rejected the female body, rather than critical readings of the question of “point of view” such as the one presented here.

10. Le Doeuff is an exception here, see her essay “Operative Philosophy: Simone de Beauvoir and Existentialism,” in E. Marks, ed., Critical Essays on Simone de Beauvoir (Boston: G. K. Hall & Co, 1987), 144-54.

11. Simone de Beauvoir, The Second Sex, Irans, by H. M. Parshley (New York: Alfred A. Knopf, Inc., 1951), xxxv; Le deuxieme sexe, 2 vols. (Paris: Gallimard, 1949), l :34. All citations from the introduction are from an unpublished translation by Beata Stawrska and Boonie Mann, the page numbers follow those of the Parshley translation. Mitsein comes from Heidegger and is German for “being- with.” For an analysis of Beauvoir’s appropriation of the term from Heidegger, see Nancy Bauer, “Beauvoir’s Heideggerian Ontology” in The Philosophy of Simone de Beauvoir, ed. by Margaret Simons (Indianapolis: Indiana University Press, 2003), 65-91. My thanks to Beata Stawarska for assistance with French translations.

12. Beauvoir herself noted the difficulty. After mentioning the difference in situation between women “of the upper middle classes and aristocracy” and “the housekeeper,” she notes: “It is as absurd, then, to speak of ‘woman’ in general, as of the ‘eternal’ man. And we understand why all comparisons are idle which purport to show that woman is superior, inferior, or equal to man, for their situations are profoundly different” (The Second Sex, 627). She also argues that women of the upper classes are more “eager accomplices” to their oppression than other women, in part because “a woman whose work is done by servants has no grip on the world” (The Second Sex,, 626-27).

13. Moira Gatens, Feminism and Philosophy: Perspectives on Difference and Equality (Bloomington: Indiana University Press, 1991), 56.

14. Tina Chanter, Ethics of Eros: lrigaray ‘s Rewriting of the Philosophers (New York: Routledge, 1995), 51.

15. Ibid., 75.

16. Celine T. Leon, “Beauvoir’s Woman: Eunuch or Male?” in Feminist Interpretations of Simone de Beauvoir, 152-53.

17. Chanter, Ethics of Eros, 48.

18. Ibid., 74.

19. Ibid., 50.

20. Ibid., 50.

21. Ibid., 61.

22. Ibid., 67.

23. For a much more positive view of Beauvoir’s appropriation of Hegel see Bauer, Simone de Beauvoir.

24. The use of “feminine” here is problematic. Beauvoir uses the term in at least two ways: to designate a condition of oppression on the one hand and as another way of saying “pertaining to women” on the other. These distinct usages tend to be entangled both in Beauvoir’s text and in the critical literature, so that the claim that Beauvoir didn’t speak “from a woman’s point of view” and the claim that she didn’t speak from a “feminine point of view” are presented as equivalent-which they are, but only if “feminine” is used in the second, rather than the first, form-and this difference generally remains unremarked. In the present essay, when I use “feminine point of view” in relation to Beauvoir, I intend the second usage, “pertaining to women”; when I speak of “the feminine condition” I intend the first usage, as I think Beauvoir did. Of course, this problem is worth a paper in itself, since women’s point of view, in the second sense, is informed and structured by the “feminine condition” in the first sense. The “woman’s point of view” that emerges in Beauvoir’s work through the exploration of multiple points of view is not simply feminine in the first sense, however, which may be what bothers some of her critics, though it is feminine in the second sense-the best word for this new point of view, however, is feminist, even though Beauvoir had not yet embraced the term herself.

25. Chanter, “Ethics of Eros,” 54.

26. Ibid.

27. Ibid., 75.

28. The Second Sex, xxxiii; Le deuxieme sexe, 1:32; cited in Chanter, “Ethics of Eros,” 53.

29. Ibid. The retraction occurs in All Said and Done, Irans. Patrick O’Brian (Harmondsworth: Penguin, 1984), 491.

30. Chanter, “Ethics of Eros,” 75.

31. The most reductive assertion in this regard belongs not to Chanter but to Leon, who states simply that “hers is indeed a male, and far from healthy, way of looking at women and sexuality,” completely failing to see that Beauvoir takes on and takes up various perspectives without affirming them as true or unproblematic (“Beauvoir’s Woman,” 143). For a defense of Beauvoir on this point on slightly different grounds than those here, see Bauer, Simone de Beauvoir, 219-23.

32. The Second Sex, xxxii-xxxiii.

33. Ibid., xxxiii-xxxiv; Le deuxieme sexe, 1:32.

34. Deutscher, fielding Gender, 192.

40. Simone de Beauvoir, The Prime of Life, trans. Peter Green (Cleveland: The World Publishing Company, 1962), 452; La Force de L’Age (Paris: Gallimard, 1960), 586 If I have amended the translation this will be indicated. The French here reads: “je ne m’etais pas avisee qu’il y eut une condition feminine” (La Force de L’Age, 586).

41. The Prime of Life, 452; La Force de L’AgeSST. Translation amended by the author. Green translates “etres relatifs” as “dependent beings.”

42. Ibid. Translation amended by the author. The French reads: “une question qui ne me touchait qu’indirectement.” Green translates this as “the problem did not concern me directly.”

38. Ibid., emphasis added. French: “Je n’accordai pas encore beaucoup d’importance.” Translation amended by the author. Green translates the passage as “as yet I contributed comparatively little importance to it.”

39. Ibid. French: “mon attention fut eveillee”.

40. The Prime of Life, 452; Force de l’Age, 586. Emphasis in the original.

41. Ibid.

42. Ibid.

43. Bauer argues that Beauvoir doesn’t come into her own, philosophically, until she comes upon the method that will allow her to write The Second Sex; see “Must We Read.”

44. Bauer, Simone de Beauvoir, 160.

45. Bauer, “Must We Read,” 134.

46. Michele Le Doeuff. “Towards a Friendly, Transatlantic Critique of The Decond Sex,” Irans. E. Grosholz, in The Legacy of Simone de Beauvoir, 31-32.

47. Ibid., 32.

48. The Second Sex, 597, Le deuxieme sexe, 2:477. Translation amended by the author. The French reads, “Nous allons essayer de prendre sur celle-ci une vue synthetique,” Parshley translates the passage as: “We shall endeavor to make a comprehensive survey.”

49. Ibid.

50. Ibid., 628.

51. Ibid.

52. Ibid., 612.

53. Ibid., xv.

54. Ibid., 597; Le deuxieme sexe 2:477. Translation amended by the author. The French reads: “elles sont integrees a la collectivite gouvernee par les males.”

55. Ibid.

56. Ibid.

57. Not all men are: “There are many men who, like women, are restricted to the sphere of the intermediary and instrumental, of the inessential means.Destined like woman to the repetition of daily tasks, identified with ready-made values respectful of public opinion, and seeking on earth naught but a vague comfort, the employee, the merchant, the office worker, are in no way superior to their accompanying females. Cooking, washing, managing her house, bringing up children, woman shows more initiative and independence than the man slaving under orders,” 624. Here it is clear that Beauvoir is dealing in gendered meanings, providing a “phenomenological inquiry into the constitution of the meaning of sexual difference” (Heinamaa, Toward a Phenomenology, xiii), while realizing that the positioning of men as well as women in relation to those meanings will be dependent on the specifics of a situation, and the situations of men are multiple, as are the situations of women. Yet it is possible, and necessary, to speak meaningfully of a “masculine” or a “feminine” condition that differently situated subjects will necessarily experience, negotiate, resist, or escape. 58. I am paraphrasing what Beauvoir says of women in the world of immanence in the negative, citing Heidegger (The Second Sex., 598).

59. Ibid., 601.

60. Ibid., 606.

61. Ibid., 607.

62. Ibid., 605.

63. Ibid., 598, 611.

64. Ibid., 598.

65. Ibid.

66. Ibid.

67. Ibid., 611.

68. Ibid., 598.

69. Ibid., 599.

70. Ibid., 602.

71. Ibid., 618.

72. Ibid.

73. Ibid., 619.

74. Ibid., 620.

75. Ibid., 619.

76. Ibid., 599.

77. Ibid.

78. Ibid., 612.

79. Gatens, Feminism and Philosophy, 49; Chanter, Ethics of Eros, 50; Leon, “Beau voir’s Woman,” 146.

80. “As long as there have been men and they have lived, they have all felt this tragic ambiguity of their condition, but as long as there have been philosophers and they have thought, most of them have tried to mask it. They have striven to reduce mind to matter, or to reabsorb matter into mind, or to merge them within a single substance. Those who have accepted the dualism have established a hierarchy between body and soul which permits of considering as negligible the part of the self which cannot be saved.” Simone de Beauvoir, Ethics of Ambiguity (New York: Citadel, 1948), 7-8.

81. The Second Sex, 611.

82. Ibid., 612.

83. Ibid., 599.

84. Ibid.

85. Ibid., 611.

86. Ibid.

87. Ibid.

88. Ibid., 612.

89. Ibid., 615.

90. Ibid., 598.

91. Ibid., 599.

92. Ibid., 617.

93. Ibid.

94. Ibid., 600.

95. Ibid., 607.

96. Ibid., 606.

97. Ibid.

98. Ibid.

99. Ibid., 612.

100. Ibid., 612; Le deuxieme sexe, 2:496. Translation amended by the author. The French reads: “On comprend que, dans cette perspective, la femme recuse la logique masculine. Non seulement celle-ce ne mord pas sur son experience, mais elle sait aussi qu’aux mains des hommes la raison devient une forme sournoise de violence; leurs affirmations peremptoires sont destinees a la mystifier.”

101. Ibid.

102. Ibid.

103.Ibid.

104. Ibid., 613.

105. Ibid., 615.

106. Ibid.

107. Ibid.

108. Ibid.

109. Ibid., 613.

110. Ibid.

111. Ibid., 612.

112. Ibid., 609.

113. Ibid., 606.

114. Ibid., 608.

115. Ibid., 606.

116. Ibid., 607.

117. Ibid., 617.

118. Ibid., 627.

119. Ibid., 610..

120. Ibid.

121. Ibid., 625.

122. Ibid., 626.

Copyright DePaul University Summer 2008

(c) 2008 Philosophy Today. Provided by ProQuest LLC. All rights Reserved.

Calypso Medical Technologies, Inc., Announces New Reimbursement Codes for Intrafraction Tracking and Implantable Transponders

Calypso Medical today announced two new reimbursement codes that enable hospital and freestanding cancer centers to properly code claims associated with the use of the Calypso(R) 4D Localization System and implanted Beacon(R) transponders.

Recently, the American Medical Association (AMA) assigned a new CPT(R) code (0197T) to “intrafraction tracking,” identifying it as a new radiation therapy procedure. Cancer centers will begin to use this code on claims effective January 1, 2009 to capture daily use of services delivered with the Calypso System. “Now, with the advent of real-time intrafraction tracking, radiation oncologists have the ability to further refine radiation therapy. The assignment of this new code validates how important real-time intrafraction tracking can be in improving the accuracy of radiation delivery,” states Patrick Kupelian, MD, Radiation Oncologist, Director of Clinical Research, M. D. Anderson Cancer Center Orlando.

Separately, the Center for Medicare and Medicaid Services (CMS) provided new guidance on the correct coding for Calypso Medical’s implantable Beacon(R) transponders. CMS recommended the use of HCPCS code A4648 and C1879 “tissue markers” associated with implantation procedures in hospital outpatient departments (C1879) and freestanding cancer centers or physician offices (A4648). HCPCS A4648 became effective January 1, 2008. Payers have the responsibility for carrier-based payment decisions at the local level for local Medicare and commercial payers for all new codes.

“The majority of Calypso prostate cancer patients are Medicare beneficiaries. We expect the availability of these new codes to increase accessibility of the Calypso System for intrafraction tracking to Medicare patients in hospitals and freestanding cancer centers. Assignment of unique codes is important; they facilitate the ability to track utilization and determine the value of new medical procedures,” notes Lynn M. Purdy, vice president, Market Development and Reimbursement of Calypso Medical.

Presently, over 60 Calypso Systems have been installed in hospital and freestanding cancer centers across the United States. Since early 2007, more than 2,000 patients have been treated with the Calypso System and have benefited from intrafraction tracking to guide their prostate cancer radiation therapy treatments.

About Calypso(R) Medical

Calypso(R) Medical Technologies, Inc. (“Calypso”) is a Seattle, WA-based privately held medical device company. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon(R) electromagnetic transponders) to continuously, accurately, and objectively pinpoint and track the location of tumors for improved accuracy and management of radiation therapy delivery. Calypso addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion management during treatment. In addition, the Calypso(R) 4D Localization System’s non-ionizing electromagnetic guidance has been found to improve workflow efficiency and treatment room utilization. The technology is designed for body-wide cancers commonly treated with radiation therapy, including prostate, breast, lung, head, neck and other radiation therapy target organs. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed.

Twenty-Six Million People Around the Globe Have Alzheimer’s

To: NATIONAL EDITORS

Contact: Katherine Kyle of the Alzheimer’s Association, +1-312- 335-5293, [email protected]

Join the Fight Against This Worldwide Epidemic on World Alzheimers Day, September 21st

CHICAGO,Sept. 21/PRNewswire-USNewswire/ — In honor of World Alzheimers Day, Sunday, September 21st, the Alzheimers Association is asking people across the globe to turn their attention to this disease and visit www.actionalz.orgto learn more and make a donation to support research and care service programs for those touched by the disease in the United States. For every dollar donated, the Alzheimers Associations national board of directors will match it dollar-for-dollar, up to $250,000.

“The number of people affected by Alzheimers is growing at an alarming rate, and the increasing financial and personal costs will have a devastating effect on the worlds economies, healthcare systems and families,” said Gerry Sampson, development chair of the Alzheimers Association National Board of Directors. “We must make the fight against Alzheimers a global priority. Its up to every one of us to learn more about the disease and join the fight.”

Currently there are more than 26 million people across the world living with Alzheimers and that number will quadruple by 2050. This means by mid-century more than 100 million people will be living with this degenerative disease that kills brain cells and eventually the person with the disease.

Did You Know

— Alzheimers disease is the sixth leading cause of death in the United States.

— 10 million American baby boomers will develop Alzheimers.

— There are approximately 5.2 million Americans living with

Alzheimers today and that number is expected to increase to

as many as 16 million by 2050.

— One out of eight people age 65 and older have Alzheimers and

nearly one out of every two over age 85 has it.

— Every 71 seconds, someone in America develops Alzheimers

disease; by mid-century someone will develop Alzheimers

every 33 seconds.

— Odds are you know or are caring for someone with Alzheimers.

There are almost 10 million caregivers in the US.

— Initial symptoms include memory loss but as the disease

progresses and kills more of the brain, the brain is unable to

tell the body how to move, swallow or breathe.

— The plaques and tangles associated with the disease act as

weeds that literally choke the healthy brain tissue causing it

to die; Alzheimers brains actually shrink due to cell loss.

The Alzheimers Associations commitment to raising awareness and funds on World Alzheimers Day is part of an accelerating worldwide effort to find better ways to treat the disease, delay its onset, or prevent it from developing, and fund programs and services for those touched by the disease, and fund programs and services for those touched by the disease.

About the Alzheimers Association

The Alzheimer’s Association is the leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimers disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimers. For more information, visit www.alz.org.

SOURCE Alzheimer’s Association

(c) 2008 U.S. Newswire. Provided by ProQuest LLC. All rights Reserved.

Hospital Bosses Admit Neglect

By Alison Dayani HEALTH CORRESPONDANT

BIRMINGHAM hospital bosses have admitted flouting health and safety rules after the death of an elderly patient who fell out of a hoist and banged her head on the floor.

South Birmingham Primary Care Trust (PCT) which runs Moseley Hall Hospital pleaded guilty to a Health and Safety Act charge over failing to ensure the correct size and type of sling was used on patients and not communicating this information to staff.

The PCT now faces a penalty of thousands of pounds in fines and costs.

Frail 90-year-old patient Alice Bell was being lifted from a commode back to bed in a sling that was too big for her by two temporary bank nurses when the accident happened, Birmingham magistrates court heard yesterday.

Mr Adam Farrer, representing the Health and Safety Executive, said Mrs Bell fell through a gap in the sling, hit her head on the floor and died at the hospital, in Alcester Road, Moseley, in March 2006.

“Mrs Bell weighed only seven and a half stone,” said Mr Farrer. “She needed assistance because she had an unpredictable sitting balance.

“The directions lacked any detail for the type or size of sling when lifting Mrs Bell into position.

“The risk of patients in slings that are too big is widely known but is easily avoidable with a simple system. Slings are now allocated on an individual patient basis but at that time there were not enough slings for each patient to have their own so there was a more random haphazard system.”

Experts said it was likely Mrs Bell died of an impact to the head but it was also possible she died of natural causes which led to her slipping.

Moira Dumma, chief executive of the PCT was in court along with Mrs Bell’s two granddaughters.

Bernard Thorogood, representing the hospital, said: “The PCT has made a frank acceptance that within a well organised system, there was a fault that the size of slings had not been specified.”

District Judge Khalid Qureshi adjourned the case to consider whether to transfer sentencing to the Crown Court.

(c) 2008 Evening Mail; Birmingham (UK). Provided by ProQuest LLC. All rights Reserved.

Mills-Peninsula Earns Top Rating for Obesity Surgery

By Maria Ginsbourg

Mills-Peninsula Health Services has again been named one of America’s top practitioners of surgery to curb obesity by HealthGrades, an independent organization that rates health care quality.

HealthGrades analyzed the quality of bariatric surgery at 680 hospitals in 17 states. The study awarded the best 93 hospitals five- star ratings. For the third year in a row, Mills-Peninsula Health Services was one of them .

Bariatric surgery limits the amount of food the stomach can hold by surgically reducing the stomach’s capacity to a few ounces.

Albert Wetter, director of laparoscopic surgery at Mills- Peninsula, said his team operates on 300 to 400 bariatric patients a year. He usually operates twice a week, three times a day.

He said doing so many surgeries is a good thing; the procedure becomes routine, which reduces the likelihood of complications. Nationally, the complication rate is only 1 percent, but Mills- Peninsula’s rate is even lower.

Rick May, author of the study, found that bariatric-surgery patients at five-star hospitals have a 65 percent lower chance of experiencing major complications than those who go to lower-rated hospitals.

Wetter said Mills-Peninsula surgeons practice laparoscopy, an innovate and noninvasive technique. Doctors operating in the traditional manner have to cut the stomach open, but doctors practicing laparoscopy create a tiny hole, into which they insert a telescopic rod equipped with a camera.

The technique allows surgeons to see and operate inside the abdomen. One of the benefits of this type of surgery is that the recovery period is shorter. Patients who undergo traditional surgery have to wait six weeks before going back to work. Laparoscopy allows people to be back on the job in two to three weeks, Wetter said.

Mills-Peninsula chief executive Bob Merwin said he was proud of the distinction.

“This HealthGrades recognition — in addition to our distinction as a Center of Excellence by the American Society of Bariatric Surgery — tells our patients they are receiving the highest quality care,” Merwin said in a statement.

Mills-Peninsula Health Services operates two local hospitals, Mills Health Center in San Mateo and Peninsula Medical Center in Burlingame.

Originally published by Maria Ginsbourg, San Mateo County Times.

(c) 2008 Oakland Tribune. Provided by ProQuest LLC. All rights Reserved.

Medics Find Quick Fix for Chest Pain

By BEN SCHOFIELD

A FASTER and more accurate treatment for a painful heart condition which affects thousands of Merseysiders was completed successfully by surgeons in Liverpool last week

Medics at the city’s Heart and Chest Centre, in Broadgreen, say the new procedure was twice as quick as the old method and promises to boost long-term success from 60% to 90%.

In the first trial of the procedure in the North West, two patients received the treatment.

Dr Johan Waktare performed what is known as the Bard Mesh Ablation on Wednesday. The patients were suffering with atrial fibrillation – a rapid heart rhythm that affects 28,000 people in Merseyside and causes excruciating and disabling chest pain. Attacks can happen once a fortnight and can last for up to two hours.

Dr Waktare, who has worked at the Heart and Chest Centre for five years, said last night: “Both procedures went well.

“We used to spend between 20 and 50 minutes burning the veins. Now, with the expandable mesh, I can do one burn in just five minutes.

“It’s quicker and simpler and possibly more successful.”

The condition is caused by a “short circuit” in the electrical network that makes the top two chambers of the heart contract.

Dr Waktare described the old method of treatment as “like painting the hallway through the letter box”. The cardiac electrophysiologist used to feed two catheters into the patient through a vein at the top of their thigh.

The first was used to map the four pulmonary veins that drain blood out of the lungs to find where the short circuit was happening, and then another catheter was then inserted and used to burn away heart tissue around the inside of the veins.

Dr Waktare then spent around four hours burning “cigarette butt- sized”

dots into the veins, hoping to complete a point-to-point circle around their inside.

But, if he inadvertently left gaps, the short circuit could still work through and cause the pain in the future.

Because of this inaccuracy, Dr Waktare said around a third of his patients returned for more treatment after two or three years.

The new procedure requires only one catheter that can both map the veins and burn them. The catheter also uses a mesh wand that expands inside the veins and can burn a complete circle in one go, which is more accurate.

Demand for treatment of atrial fibrillation at the Heart and Chest centre has surged from 250 procedures five years ago, to around 950 a year now.

The tool was developed by Bard Electrophysiology.

A spokesperson for the firm said it was a “simple to use, safe and effective therapy” which “may reduce overall procedure complexity and time.”

[email protected]

(c) 2008 Daily Post; Liverpool. Provided by ProQuest LLC. All rights Reserved.

It Keeps You Running

By Ken Newton

The wood-chip trail offers a measure of kindness to what Terry Seiter calls his “old-man body.” The description proves a self- mocking dodge.

A picture of aerobic fitness, Mr. Seiter suffers few of the ailments of long-time runners. His joints give him no real problems. His muscles, sure, hurt at times, but ice and ibuprofen do wonders.

But that misses the point, anyway. The 48-year-old St. Joseph man accepts the physical aches because of the rewards he finds in running.

On the impact-absorbing wood chips on the loop at Missouri Western State University, where he runs more than six miles most days, he solves computer problems or plans training sessions or generally lets the oxygen enrichment eat away some of life’s stresses.

Terry Seiter, right, and a running companion pound out mileage on the nature trails at Missouri Western State University.

Photo by Zachary Siebert / St. Joseph News-Press / Purchase this photo

Terry Seiter, right, and a running companion pound out mileage on the nature trails at Missouri Western State University.

Mr. Seiter stands convinced it makes him a better person.

Non-runners may not get it, he concedes. You either love running or tolerate it.

“It’s very rare that you’ll see that look of misery on my face,” he says.

This satisfaction comes hard-won. With this month’s end, Mr. Seiter has logged 57,400 miles of running. In increments of daily dedication, he has equivalently circled the Earth more than twice.

Flash back 29 years and that achievement would seem far-fetched. A native of St. Joseph and 1977 graduate of Central High School, Mr. Seiter went to Missouri Western and had what he calls a “college lifestyle.” In short, he went from a 165-pound guy to a 190-pound guy.

“I’m just getting my driver’s license back, and I’m looking at the picture,” he remembers. “I’m thinking, ‘Wow, you’ve got a lot of chins there.’ It didn’t pack on to me very well.”

His younger brother Ted had qualified for state competition as a high school runner. One miserably hot day in September 1979, he introduced a forced-march method of training that Terry doesn’t recommend for running novices these days.

“He and his friend, they sandwiched me and made me run four miles,” Terry says. “They did that to me for almost a month.”

When the two of them phased out, Mr. Seiter kept running on his own. The next spring, he took part in a 10-kilometer race in Columbia. The runner crossed the finish line in the University of Missouri football stadium and, though the cheering was not specifically for him, he gained an affinity for the competitive aspects of running.

Mr. Seiter had a lot to learn about training. There are hill programs, sprint up and jog down, to build leg strength. There are pace workouts … sprint to one light pole on the city’s Parkway, jog to the next. There is track work, the 200s and 400s, always with time goals.

In 1987, he picked Kansas City as the site of his first marathon. It still bugs him, the only race he never finished.

“I was in shape physically, but I wasn’t ready for it up here,” he says, pointing to his head.

Mr. Seiter took the race number he wore that day and put it by his back door. Every day when he left to run, he would see it as a reminder.

About that time, the runner began improving his diet to match the hours of training. More weight vanished. The training regimen hit 80 to 90 miles a week as he prepared for the next year’s race in Kansas City.

In a pouring rain most of the time, Mr. Seiter finished that marathon in two hours and 50 minutes, exactly the goal he set.

The runner has participated in six marathons since, including the most famous, Boston, in 1993. There were also hundreds of shorter races. He credits his wife, Marlene, and his two children for letting him indulge in this passion, spending a lot of weekends in motels in far-flung towns where he raced. “I dragged them around a lot,” he says.

For him, running also serves as a means of tourism. In Los Angeles, he knows the course around the Staples Center and past the USC campus. In Chicago, he prefers the lakefront trail to risking the downtown stop signals. (“Only a suggestion,” he believes of the drivers’ regard for red lights.)

From his information systems consultancy at American Family Insurance, he crosses the road for daily runs at the university, keeping a pace of about seven and a half minutes a mile and logging about 40 miles a week. Mr. Seiter runs year-round, the hotter the better, he says. In the winter, slippery ground sometimes makes his knees swell.

He goes through a pair of running shoes about every 500 miles. If the numbers don’t tell him, his calves do. The runner trusts the knowledge of his legs.

“Your body knows the difference between a little fleeting pain and when something’s wrong,” Mr. Seiter believes.

One day, he says, the body will revolt. But the runner enjoys a trail with the crunch of wood chips underfoot, likes to collect his thoughts as the scenery rushes by. He’ll trade some soreness for these moments every day.

Ken Newton can be reached

at [email protected].

(c) 2008 St. Joseph News-Press. Provided by ProQuest LLC. All rights Reserved.

Five-Year Data Confirm That Early Treatment With Betaseron(R) at First Sign of Disease Can Delay Progression to MS

MONTREAL, Sept. 20 /PRNewswire/ — Bayer HealthCare Pharmaceuticals announced today that new data from its BENEFIT (BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment) study confirm that early initiation of Betaseron(R) (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) significantly delayed the onset of clinically-definite MS (CDMS) by 37 percent (p=0.003) and McDonald MS by 45 percent (p

“The BENEFIT five-year results are the first and only prospectively planned data to confirm a continuous benefit over five years when treatment is initiated shortly after the earliest sign of MS,” said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and investigator of the study. “These results confirm that treatment with Betaseron after the first MS event or attack can reduce the risk of developing MS over five years compared to delayed treatment.”

The study also demonstrated that early treatment with Betaseron had a beneficial effect on cognition that became even more pronounced over time. At five years, patients with early treatment had better cognitive function (mean PASAT score) compared to patients with delayed treatment (p= 0.0045).(1) PASAT, or the Paced Auditory Serial Addition Test, is a widely accepted tool that measures intellectual function and cognition.

“Changes in cognitive function have important implications for a patient’s quality of life. Changes in cognition, along with fatigue, can be a reason for early departure from the workforce. Patients treated early with Betaseron fared better in tests of cognitive function compared to those with delayed treatment, which is good news for people with MS,” Dr. Freedman said.

The BENEFIT study was the first to demonstrate a reduction in the risk of confirmed EDSS progression, as measured by the Expanded Disability Status Scale (EDSS), with early versus delayed treatment. This effect first appeared at year three, with a significant risk reduction of 40 percent (p=0.022).(2) Over five years, a nominal risk reduction of 24 percent (p=0.177) was observed for early treatment compared to delayed treatment. This difference over five years was not statistically significant.(1)

The key findings from the BENEFIT five-year study showed that:(1)

— Starting Betaseron after the first clinical event delayed the development of CDMS by more than two years (750 days) in the 40th percentile.

— Patients treated early with Betaseron had a greater reduction in relapse rate over five years compared to patients with delayed treatment, (0.21 versus 0.27) despite the latter receiving at least three years of treatment after the second attack or after two years (p=0.014; Poisson model). This effect was mainly due to the differences between the groups during the first two years.

— Early treatment significantly reduced the development of newly active brain lesions (new or enlarging T2 lesions, Gd-enhancing lesions) compared to delayed treatment (p=0.0062).

— In the BENEFIT study there was a high level of study completion of Betaseron by patients with the earliest signs of MS. Two-thirds of patients (67 percent) in the early treatment group continued on Betaseron for five years.

— Patients consistently reported a high Health-Related Quality of Life over the five-year study period.

Adverse events (AEs) reported at five years were consistent with the product label.

About BENEFIT

BENEFIT is the first and only prospectively planned five-year MS study to demonstrate the long-lasting benefits of initiating Betaseron (interferon beta-1b) after the first clinical event suggestive of MS. Overall, results from the trial showed that early initiation of Betaseron treatment in patients with the earliest signs of the disease delayed the progression to CDMS and McDonald MS, and improved cognitive function as measured by PASAT.

The multi-center trial was conducted at 98 sites in 20 countries and included patients presenting with a single clinical episode suggestive of MS. A total of 468 patients with a first clinical demyelinating event suggestive of MS and typical MRI findings were randomized to receive either 250 micrograms of Betaseron every other day or placebo as a subcutaneous injection in a double blind fashion for a maximum of two years. The study was designed to encompass a representative population of patients with the earliest signs of MS, including patients with mono- or multifocal lesions.

The placebo-controlled treatment period lasted up to 24 months or up to the time when patients were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaseron to prospectively assess the impact of such early versus delayed treatment with Betaseron on the long-term course of the disease for a total observation time of five years.

“Early treatment” refers to treatment initiated after the first clinical event; “delayed treatment” refers to treatment initiated after the second clinical event or after two years, whichever occurs first.

About Betaseron

Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Betaseron should be used with caution in patients with depression. Injection-site necrosis has been reported in four percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See “Warnings,””Precautions,” and “Adverse Reactions” sections of full Prescribing Information. More information, including the full Prescribing Information, is available at http://www.betaseron.com/.

About Multiple Sclerosis

MS is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS. Symptoms of MS vary from person to person and can be unpredictable. They may include: fatigue or tiredness, dimness of vision in one or both eyes, weakness in one or more extremities, numbness and tingling in the face, arms, legs and trunk of the body, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) MS Freedman, L Kappos, CH Polman, et al. Impact of Early Interferon beta-1b Treatment on Disease Evolution Over 5 Years in Patients with a First Event Suggestive of Multiple Sclerosis. World Congress on Treatment and Research in Multiple Sclerosis 2008.

(2) Kappos L et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 2007 Aug 4; 370(9585): 389-97

Bayer HealthCare Pharmaceuticals Inc.

CONTACT: Marcy Funk of Bayer HealthCare Pharmaceuticals,+1-973-305-5385, [email protected]

Web site: http://www.berlex.com/http://www.betaseron.com/

Survey Finds Megachurches Can Be Friendly

A Baylor University study finds that very large churches in the United States are in some ways friendlier and more intimate than smaller ones.

Byron Johnson, director of the Institute for Study of Religion at the Texas university, told the Fort Worth (Texas) Star-Telegram that mega churches provide opportunities for members to get together in small groups.

“People get to know each other in very close ways,” Johnson said. “They can share their imperfections and struggles, and people are checking in on you and praying for you. … Many have single parents’ groups on how to handle finances, on English as a second language. Here’s the church saying, ‘We care about this part of your life. … We aren’t here to condemn but to help.'”

Baylor began a regular series of surveys conducted by the Gallup Organization in 2005. They are to be done every two years with the last one released in 2018.

The most recent survey also found that regular churchgoers are less likely to believe in UFOs, Big Foot, the Loch Ness monster and similar phenomena.

Gallup surveyed 1,648 English-speaking adults for the most recent poll.

Calypso Medical’s Real-Time Tracking Technology in Radiation Therapy Highlighted in 23 Clinical Presentations at the 50th Annual ASTRO Scientific Sessions

Calypso Medical Technologies, Inc. today announced that 23 abstracts highlighting the use of the Calypso(R) 4D Localization System(TM) will be presented this week at the 50th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) at the Boston Convention and Exhibition Center. The studies report on a wide range of benefits of the Calypso System.

The Calypso System is the only real-time target tracking system used to manage tumor motion during treatment delivery. The ability to manage motion during radiation therapy is a critical advancement that assures the clinician and the patient that the radiation treatment prescribed is delivered to the cancerous tissue while avoiding adjacent healthy organs. Known as GPS for the Body(R), the Calypso System utilizes implanted Beacon(R) electromagnetic transponders, smaller than a grain of rice, to enable continuous tracking of the prostate during radiation treatment.

The results of a study entitled “Geometric Accuracy and Latency of an Integrated 4D IMRT Delivery System Using Real-Time Internal Position Monitoring and Dynamic MLC (multileaf collimator) Tracking” will be presented by Dr. Amit Sawant of Stanford University. Dr. Sawant’s research focuses on using dynamic MLC technology to respond to respiratory motion during therapy. This research demonstrates that the Calypso System is capable of guiding the delivery of radiation to moving tumors with sub-millimeter accuracy by tracking a target in real-time.

A significant amount of research has been performed assessing the utility of the Calypso System in managing prostate motion. Among the highlights is a study (“Prostate Patient Setup Error and Organ Motion Error for Conventional and Hypo-Fractionated Radiation Therapy”) by Dr. Zhong Su, et al., demonstrating the high probability of inter-fraction set-up errors that could be eliminated with Calypso-guided online setup. Dr. J. R. Olson, et al., in “Individual Margin Determination for Prostate Cancer Patients Undergoing Real-Time Tracking” showed the importance of monitoring patient-specific rotation because it can lead to inadequate PTV coverage.

The importance of real-time tracking was also evaluated in new clinical areas. The results of a study conducted by Dr. M. L. Mayse, et al., entitled “Development of a Non-Migrating Electromagnetic Transponder System for Lung Tumor Tracking” showed the feasibility of using stabilized transponders in the lung. The potential of using transponders to monitor lung motion could prove to be an essential factor in lung cancer radiation therapy management. In “Feasibility of AC Electromagnetic Localization for External Beam Partial Breast Irradiation” by Dr. Stephen Eulau, et al., the Calypso System was used to localize and continuously track the lumpectomy cavity during partial breast radiation therapy. The authors concluded Calypso’s technology provides an efficient means to correct setup errors and manage intrafractional motion, even after couch kicks. In addition, they pointed out that continuous tracking could potentially enable the use of tighter treatment margins.

“It is very encouraging to see the large and growing body of scientific work demonstrating the many advantages of the Calypso System,” said Eric R. Meier, CEO and President of Calypso Medical. “As the evidence shows, continuously tracking the position of the prostate or other vital organs during radiation treatment provides clear clinical benefits for physicians and their patients.”

 Geometric Accuracy and Latency of an Integrated Intrafraction Motion Management System Using Real-Time Internal Position Monitoring and Dynamic MLC Tracking Amit Sawant, et al., Stanford University, Palo Alto, Calif. Monday, Sept. 22nd, 11:35 a.m., Room 258.  Prostate Displacement During and After Transabdominal Ultrasound (US) Guidance, Monitored by a Real-Time Tracking System B. J. Salter, B. Wang, M. Szegedi, J. D. Tward, D. C. Shrieve, Huntsman Cancer Institute, Salt Lake City, Utah. Tuesday, Sept. 23rd, 1:45-3:15 p.m., Room 157.  Gains from Real-Time Prostate Motion Monitoring During External Beam Radiation Therapy J. Li, L. Jin, E. Horwitz, A. Pollack, S. Johnston, R. Price Jr., and C. Ma, Fox Chase Cancer Center, Philadelphia, Pa. #2265.  Daily Isocenter Correction During Prostate Radiotherapy (RT) Helps to Avoid Significantly Decreased Target Volume Dose and Increased Rectal Dose R. R. Rajendran, D. L. McMichael, A. Kassaee, J. P. Plastaras, N. Vapiwala, University of Pennsylvania Medical Center, Philadelphia, Pa. #2267.  Bevacizumab in Combination with Androgen Deprivation and IMRT in Patients with High Risk Prostate Cancer H. T. Pham, S. Warren, R. A. Hsi, B. L. Madsen, G. S. Song, K. R. Badiozamani, J. Vuky, Virginia Mason Medical Center, Seattle, Wash. #2281.  Clinically Useful Observations of Prostate Motion Using Calypso(R) 4D Localization System Jay Shelton, MD; Tomi Ogunleye, MS; Ashesh B. Jani, MD, M.S.E.E.; Eric Elder, PhD; Peter J. Rossi, MD, Emory University School of Medicine, Atlanta, Ga. #2291.  Evaluation of Interfraction and Intrafraction Prostate Motion During the Treatment of Prostate Cancer Using the Calypso 4D Localization System R. A. Hsi, F. Vali, H. Parsai, E. Garver, B. Madsen, H. Pham, G. Song, K. Badiozamani, P. Cho, Virginia Mason Medical Center, Seattle, Wash. #2292.  A Phase II Trial of Trilogy-Based Prostate SBRT: Report of Favorable Toxicity and Early Biochemical Outcomes Constantine Mantz, MD; Eduardo Fernandez, MD; Steven Harrison, MD; Ira Zucker, MD, 21st Century Oncology, Fort Myers and Plantation, Fla. #2317.  Quantifying Respiratory-Induced Prostate Motion Using Continuous Real-Time Tracking Technology T. L. McDonald, L. Ku, K. M. O'Donnell, D. Kaurin, P. J. Gagnon, C. R. Thomas, A. Y. Hung, M. Fuss, Oregon Health & Science University, Portland, Ore. #2369.  Non-Gaussian Nature Of Prostatic Motion Using Real-Time Tracking and Its Impact on Treatment Margins M. K. Khan, A. M. Mahadevan, Q. Chen, Cleveland Clinic, Cleveland, Ohio. #2374.  Real-Time Prostate Motion is Highly Variable Among Patients Undergoing Prostate Radiotherapy (RT) with Electromagnetic Localization and Tracking N. Vapiwala, R. R. Rajendran, J. P. Plastaras, A. Kassaee, University of Pennsylvania Medical Center, Philadelphia, Pa. #2405.  Development Of A Non-Migrating Electromagnetic Transponder System For Lung Tumor Tracking M. L. Mayse, R. L. Smith, M. Park, G. H. Monteon, E. H. Silver, P. J. Parikh, E. Nielson, D. L. Misselhorn, M. R. Talcott, S. Dimmer, et al., Washington University School of Medicine, St. Louis, Mo. #2584.  Feasibility of AC Electromagnetic Localization for External Beam Partial Breast Irradiation Stephen Eulau, Astrid Morris, Paula Hallam, Muhammad Afghan, Jin- Song Ye, Tricia Zeller, Timothy Mate, Swedish Cancer Institute, Seattle, Wash. #2783.  Impact of Localization Technique on the Accuracy of Daily Repositioning of Prostatic Isocenter During Radiotherapy T. He, D. G. Kaurin, J. Tanyi, J. Wu, W. D'Souza, M. Fuss, A. Hung, Oregon Health Sciences University, Portland, Ore. #2840.  Prostate Gland Motion in Prone and Supine Positions Assessed in Real-Time by Implanted Electromagnetic Transponders Wayne M. Butler, PhD; Brian S. Kurko, MS; Brian C. Murray, BS; and Gregory S. Merrick, MD, Schiffler Cancer Center, Wheeling Hospital, W.Va. #2861.  Automatic Deformable Registration on Prostate Cine-MRI Images for Studying Intra-Fraction Motion in Supine and Prone Position with and without Rectal Balloon W. C. Hsi, C. Vargas, A. Saito, J. F. Dempsey, S. Keole, L. Lin, S. Flampouri, Z. Li, J. Palta, Florida Proton Therapy Institute, Jacksonville, Fla. #2866.  Prostate Patient Setup and Organ Motion Error for Conventional and Hypo-Fractionated Radiation Therapy Zhong Su, Yousaf Falukhi, Martin Murphy and Jeff Williamson, Virginia Commonwealth University, Richmond, Va. #2890.  Individual Margin Determination for Prostate Cancer Patients Undergoing Real-Time Tracking Jeff Olsen, Camille Noel, Lakshmi Santanam, Jeff Michalski, Parag Parikh, Washington University School of Medicine, St. Louis, Mo. #2904.  Dosimetric Influence of Intrafraction Prostate Motion on IMRT Treatment with Sliding Window Dynamic Mulitleaf Collimator Technique W. Fu, Y. Yang, N. J. Yue, R. Selvaraj, A. Chen, K. Mehta, D. E. Heron, M. S. Huq, University of Pittsburgh Cancer Institute, Pittsburgh, Pa, The Cancer Institute of New Jersey, New Brunswick, N.J. #2910.  IMRT Dosimetric Measurements from a Real-Time Internal Position Monitoring System Coupled with a Dynamic Multileaf Collimator Tracking System Ryan L. Smith, et al., Washington University School of Medicine, St. Louis, Mo. #2988.  The Effect of Transponder Motion on the Accuracy of the Calypso Electromagnetic Localization System M. J. Murphy, R. Eidens, E. Vertatschitsch, J. Wright, Virginia Commonwealth University, Richmond, Va. #2994.  Clinical Experience with 4D PET/CT to Account for Intrafraction Motion in Radiation Oncology A. P. Shah, A. P. Santhanam, T. R. Willoughby, P. A. Kupelian, S. L. Meeks, M.D., Anderson Cancer Center Orlando, Orlando, Fla. #3041.  Clinical Use of Electromagnetic Guidance for Lung and Spine Radiation Therapy T. R. Willoughby, A. P. Shah, A. R. Forbes, R. R. Manon, P. A. Kupelian, S. L. Meeks, MD, Anderson Cancer Center Orlando, Orlando, Fla. #3053. 

About Calypso(R) Medical

Calypso(R) Medical Technologies, Inc. (“Calypso”) is a Seattle, WA-based privately held medical device company. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon(R) electromagnetic transponders) to continuously, accurately, and objectively pinpoint and track the location of tumors for improved accuracy and management of radiation therapy delivery. Calypso addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion management during treatment. In addition, the Calypso(R) 4D Localization System’s non-ionizing electromagnetic guidance has been found to improve workflow efficiency and treatment room utilization. The technology is designed for body-wide cancers commonly treated with radiation therapy, including prostate, breast, lung, head, neck and other radiation therapy target organs. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed.

Scientists Use Satellites to Track Endangered Species

For the first time ever, scientists will use satellites in space to monitor the fluctuations of endangered species populations.

The scientists will use satellite photos to count and monitor giant kangaroo rats, a key indicator for the health of a dry plains environment. The photos will be obtained from the same satellites the Israeli defense forces use, and will be compared with 30 years of satellite images released this month by the U.S. Geological Survey. 

Researchers aim to use this data to determine the impact of climate change and other conditions, such as the transformation of California’s once-arid San Joaquin Valley into a mosaic of highly cultivated farms, which have forced the giant kangaroo rats to higher ground. Farming has robbed the rats of 90 percent of their habitat since the middle of last century.

The information obtained from the satellites will also help scientists assess when cattle could be used to reduce nonnative grasses, something that would make it easier for the rodents to find food.

The research is being conducted on the large Carrizo Plain, a 390-square-mile desert region 150 miles southwest of Fresno and home to the most concentrated remaining populations of kangaroo rats. The Carrizo Plain National Monument is California’s largest unmolested tract of grasslands, and is similar in biology and geography to the San Joaquin Valley. It supports many animal and plant species that once thrived in the area.

“Carrizo is like a Yosemite for grasslands, and there are decisions people are learning to make to manage it in a way that preserves its natural state,” Tim Bean, a University of California doctoral student with the department of environmental policy and management, told the AP.

“Since the kangaroo rat is so important to its function, we’ve got to get a handle on it.”

The use of satellite technology replaces trapping and dreary airplane flyovers as a way of obtaining population counts.

“It allows us to more quickly recognize whether populations are declining where we want them to exist,” Scott Butterfield, a biologist with of The Nature Conservancy, told the Associated Press.

“If they go below a threshold, that is when we would consider intervening.”

Giant kangaroo rats are nocturnal rodents named for their ability to hop on their back legs. Their plump, five-inch bodies are a favored food source of the endangered kit fox. They adapted to their desert environment by removing moisture from seeds and from within their nasal passages from the humid air they exhale.

The rats gather seeds from native grasses in circles outside their burrows to obtain food. These burrows also serve as shelter for the endangered San Joaquin antelope squirrel and blunt-nosed lizards.

Increasing rainfall promotes the growth of taller nonnative grasses, which can often overrun the shorter grasses that kangaroo rats use for food. Less food results in fewer offspring and a declining population. When this happens, the endangered native plant and animal species that depend on the rats for survival also decline, according to researchers.  

Determining the precise point at which falling rainfall affects foraging will help the U.S. Bureau of Land Management (BLM) set an appropriate grazing policy to control nonnative grasses and restore the kangaroo rat population.

“Without them the entire ecosystem would go out of whack,” Bean said.

“It’s fairly rare for something so small to be a keystone species. It’s easier to track, say, bison.”

Cahava Spring Development Announces Dr. Ramsey’s Center for Natural Healing As Community Health & Wellness Medical Director

CAVE CREEK, Ariz., Sept. 19 /PRNewswire/ — Pyramid Developers, developer of Cahava Springs, is very pleased to announce Dr. Theresa Ramsey and her Center for Natural Healing (“CFNH”) as the Health and Wellness Medical Director for the community. Cahava Springs is the only non-age restricted community in Arizona to have a Health & Wellness Director as part of the overall lifestyle program for residents. Cahava is a sustainable, preservation community focused on the health and wellness of not only the land but of the residents who will live there. To achieve this goal, just as Pyramid Developers created the Cahava Springs Conservancy to preserve the land, it has partnered with Dr. Theresa Ramsey to design and manage the Health and Wellness program for the sustainable wellness of Cahava residents. To best support the health and the residents of Cahava Springs, Dr. Ramsey’s Center for Natural Healing will have a medical office/clinic set up at the Cahava Springs community center to advise and treat residents. The Residents can also visit The Center in Paradise Valley at any time; have access on-line at a secure web site and phone consultations no matter where the resident actually is, taking advantage of their same benefits and discounts. The Health and Wellness benefits to each resident will be:

   -- Lifestyle coaching;   -- Nutrition and diet advise including specific diet plans and use of      supplements;   -- Physician from Dr. Ramsey's Center for Natural Healing will be one site      one day per week increasing as needed;   -- Lifestyle Program designed by Dr. Ramsey and managed by The Center will      be offered and accessible by residents in person, on-line and by phone;   -- Monthly on-site educational seminars;   -- 20% discount on services and programs offered by Dr. Ramsey's Center      for Natural Healing;   -- 10% discount on all supplements and products sold by Dr. Ramsey.    

Cahava Springs, a 230 custom home “conservation development” located in Cave Creek, Arizona, was created by Pyramid Developers, an Arizona-based LLC. The Development is planned to be the most sustainable planned community in Arizona, and has a non-for-profit conservancy, Cahava Springs Conservancy. The Cahava Springs Conservancy is a sustainable organization committed to preserving in perpetuity the natural beauty and historical significance of the 942-acre Cahava Springs property, 80% of which is preserved as open space. The Conservancy also owns and seeks to enhance the property’s 130-acre Apache Springs Nature Preserve that is home to a rare and sensitive riparian habitat and the front door to the Cahava Springs residential community. When combined with the Health & Wellness Program with Dr. Ramsey, Cahava seeks to preserve the person as well as the place. For information on the Cahava Springs Community please visit http://www.cahavasprings.com/ or Erin Ludwig at 1.800.893.2738 X-17. For information on The Center for Natural Healing visit: http://www.drramsey.com/ or contact Kacee Sissener at (480-945-1396) and for information about Pyramid Developers please visit http://www.pyramidcd.com/

Pyramid Developers

CONTACT: Erin Ludwig, Director of Corporate Communications of PyramidDevelopers, 1-800-893-2738, ext. 17, [email protected]

Web site: http://www.pyramidcd.com/http://www.drramsey.com/http://www.cahavasprings.com/

AseraCare Hospice Helps Patients and Employees After Hurricane Ike Leaves Many Displaced

Care for the terminally ill cannot stop — even after the ravages of Hurricane Ike. Despite severe damage that left its Houston and Shenandoah offices without water and power, AseraCare Hospice is continuing to provide needed care and service to its patients.

Both offices are operating remotely with the assistance of the AseraCare Hospice office in Round Rock, just north of Austin. This office is the current triage site for all patients and employees.

More than half of the 30 AseraCare Hospice staff members are without water and power, or have been displaced from their homes. AseraCare Hospice and its staff are finding resourceful ways to continue providing care — despite their own personal difficulties and hardships.

The company is using a fuel tank staged south of Houston so that caregivers have access to gas so they can see their patients. Special arrangements were also made so that patients dependent on oxygen, to manage their terminal illness, were never interrupted.

“As a company, we’re wrapping support around our patients as well as our employees,” said Bob Donovan, President of AseraCare Hospice. “We are especially thankful for the EMS representatives in Montgomery and Harris counties who have been checking on our patients when we aren’t able to.”

The AseraCare Hospice staff continues to work with each other covering the patient load, even if it means driving much further to a patient’s home or working longer hours to cover the care. They’re even devoting their time to assist one another at home with the special needs that have arisen due to the lack of utilities.

Community support and volunteers are contributing in various ways to help the AseraCare Hospice staff and the patients affected by Hurricane Ike. H-E-B Grocery stores, Home Slice Pizza, Chick-Fil-A restaurants, and the team of EMS Capt. Paul Sims, all have provided food, drinks and other necessary help to Houston evacuees.

“Our entire organization is appreciative of the people in Houston and Austin for their outpouring of support during this tough time,” said Cindy Susienka, President and CEO of Golden Innovations, parent company of AseraCare. “We are so grateful for the community’s assistance in the distribution of medical supplies, food and water to our patients and our employees in need.”

High School Scoreboard

By BAY AREA NEWS GROUP

GOLF

High school girls

HAAL San Leandro 202, Moreau Catholic 222

At Mission Hills GC, Par 36

34 — Linda Brown (SL); 38 — Jem Marasigan (SL); 38 — Jessica Salas (MC); 39 — Nicolette Vera Cruz (SL); 43 — Anne Wang (MC); 45 — Rachel Tamayosa (SL); 46 — Maia Estropia (SL); 47 — Alicia Martinez (MC); 56 — Olivia Vera (MC); 58 — Natalie Bright (MC). Records: San Leandro 3-1 HAAL, Moreau Catholic 0-3.

Mission San Jose 212, Bishop O’Dowd 273

At Metropolitan GC, Par 36

36 — Bonnie Hu (MSJ); 42 — Cathy Lee (MSJ); 43 — Madison Hirsch (MSJ); 44 — Taneesh Sra (MSJ); 47 — Mollie Montgomery (BOD), Candice Koh (MSJ); 51 — Daniella Johnson (BOD); 54 — Tori Burns (BOD); 60 — Alex White (BOD); 55 — (); 61 — Jennifer Louie (BOD). Records: Mission San Jose 3-1, Bishop O’Dowd 3-1.

tennis

High school girls

Tuesday HAAL Bishop O’Dowd 7, Mt. Eden 0

Individual results not available. Records: Bishop O’Dowd 1-0 HAAL, Mt. Eden 0-1.

VOLLEYBALL

High school girls

Nonleague Washington d. Livermore

Scores: 25-22, 25-18, 18-25, 25-16. Highlights: W — Kellie Ishisaki 6 digs, 7 kills; Kristina Ramoa 9 kills, 3 blocks; Ashley Hess 7 kills, 4 digs; Amanda Richards 6 aces, 4 digs.

Tuesday

MVAL Washington d. Kennedy-Fremont

Scores: 25-17, 25-15, 25-17. Highlights: W — Chessie Santeramo 15 assists; Jenelle Serex 4 kills; Kaylee Miu 5 kills, 4 aces; Kelsey Harrington 6 aces; Kori Guerra 3 kills. Records: Washington MVAL, Kennedy-Fremont .

SLATE

TODAY

College

WOMEN’S VOLLEYBALL — Simpson at Cal State East Bay, 5 p.m.

High school

GIRLS TENNIS — Tennyson at San Leandro, Hayward vs. Moreau Catholic at Hidden Hills, Arroyo vs. Bishop O’Dowd at Harbor Bay, San Lorenzo at Mt. Eden, all 3:30 p.m.

GIRLS GOLF — Mission San Jose vs. Arroyo at Skywest, Castro Valley vs. Moreau Catholic at Mission Hills, both 3 p.m.

GIRLS VOLLEYBALL — Irvington at Mission San Jose, Newark Memorial at Kennedy-Fremont, James Logan at American, 3:45 p.m.; Alameda at San Leandro, 5 p.m.

FOOTBALL — Albany vs. Mission San Jose at TAK, 7 p.m.

FRIDAY

College

WOMEN’S SOCCER — Cal State East Bay at William Jessup, Foothill at Chabot, both 4 p.m.

MEN’S SOCCER — West Valley at Chabot, 6:30 p.m.

High school

FOOTBALL — San Lorenzo vs. Alameda at Thompson Field, Mt. Eden at Amador Valley, San Ramon Valley vs. San Leandro at Burrell Field, Mission-S.F. vs. Hayward at Sunset Field, Foothill at James Logan, Livermore vs. Irvington at TAK, American at Oakland, Newark Memorial at Milpitas, all 7 p.m.

SATURDAY

College

MEN’S SOCCER — Fresno Pacific at Cal State East Bay, 2 p.m.

CROSS COUNTRY — Cal State East Bay at Westmont Invitational in Santa Barbara, 9:30 a.m.

FOOTBALL — Chabot at San Jose, 7 p.m.

High school

FOOTBALL — Castro Valley at Berkeley, 1:30 p.m.; Moreau Catholic at Arroyo, Kennedy-Fremont at Bishop O’Dowd, Overfelt-San Jose at Tennyson, all 1:45 p.m.; College Park at Washington, 7 p.m.

CROSS COUNTRY — Hayward High Invitational, 9 a.m.

GIRLS VOLLEYBALL — Arroyo at Albany Invitational, 9 a.m.

(c) 2008 Oakland Tribune. Provided by ProQuest LLC. All rights Reserved.

Delcath Systems Targeted Drug Delivery Technology to Be Presented at Western Angiographic and Interventional Society Annual Meeting

Delcath Systems, Inc. (NASDAQ: DCTH), a leading developer of regional therapy for cancer, today announced that Dr. Charles Nutting of Swedish Medical Center in Englewood, Colorado will deliver a presentation at the 38th Annual Meeting of the Western Angiographic and Interventional Society (“WAIS”). Dr. Nutting will discuss his involvement with Delcath’s Phase III trial of its Percutaneous Hepatic Perfusion (PHP) System for the treatment of inoperable metastatic melanoma at the conference, held in Maui, Hawaii from September 20-25, 2008.

Dr. Nutting, a Principal Investigator on the Phase III trial, will present Delcath’s PHP technology and its role in the treatment of liver metastases. Dr. Nutting has been at the forefront of regional therapy for the treatment of cancer, and is a leader in the field of interventional oncologic techniques. He has recently joined the Delcath trial, as the Principal Investigator at Swedish Medical Center, one of the nine enrolling centers for the randomized Phase III trial.

“Dr. Nutting’s presentation marks an expansion in awareness for the Delcath PHP System,” stated Richard L. Taney, President and CEO of Delcath. “This is the first major presentation regarding the Phase III trial by an Investigator outside of the National Cancer Institute. As the oncology community becomes more familiar with the potential benefits of Delcath’s PHP technology, this presentation will further the awareness of the Interventional Radiology Community which will be a key driver in the adoption of this unique treatment for inoperable cancers.”

WAIS is a regional society of leading physicians from the western states and Canada dedicated to vascular and interventional radiology, and image-guided techniques for the diagnosis and treatment of cancer and other illnesses. Information on this organization and conference can be found at www.westernangio.org.

About Delcath Systems, Inc.

Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company has developed a proprietary, patented system which will improve the efficacy of cancer treatment while reducing the considerable, systemic side-effects of chemotherapy. Delcath’s novel drug delivery platform is capable of delivering anti-cancer drugs at very high doses to a specific organ or region of the body while preventing these high doses of drug from entering the patient’s bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company’s intellectual property portfolio consists of twenty-eight patents on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company’s website at www.delcath.com.

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

 Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 Email Contact  Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper/Cass Almendral (212) 838-1444 Email ContactEmail Contact  Public Relations Contact: Rubenstein Associates, Inc. Robin Wagge (212) 843-8006 Email Contact

SOURCE: Delcath Systems, Inc.

A Romanian Pharmaceuticals and Healthcare Report, Q3 2008: Understand the Regulatory Regime, the Competitive Landscape & Recent Developments

Research and Markets (http://www.researchandmarkets.com/research/a4c187/romania_pharmaceut) has announced the addition of the “Romania Pharmaceuticals and Healthcare Report Q3 2008” report to their offering.

Our Romania Pharmaceuticals and Healthcare Report provides independent forecasts and competitive intelligence on Romania’s pharmaceuticals and healthcare industry.

In our adjusted Business Environment Rankings for Central & Eastern Europe (CEE) for Q308, Romania is found in a joint ninth position, on a par with Slovenia. The country’s pharmaceutical rating, which corresponds to the region’s average, masks the strong forecast growth of in the first half of the forecast period. Key weaknesses of the market include chronic funding shortages, which have resulted in severe payment delays, cumbersome bureaucracy and widespread corruption.

On a positive note, from the start of April 2008, new legislation stipulates that doctors need to prescribe specific brands rather than international non-proprietary names (INN’s), which will stimulate the growth of the branded market. The requirement should also allow wholesalers and pharmacies to continue enjoying the larger profit margins from branded medications. However, this could be off-set by the government’s current price structuring programme, which – by not accurately reflecting currency fluctuations – is decreasing profit margins on imported goods.

In fact, in February 2008, the Romanian association of pharmaceutical distributors and importers (ADIM) called for more flexibility to increase drug prices in order to offset the impact of a depreciating currency. Under current regulations, prices are adjusted according to exchange rates every three months, although – in practice – the increases have not been granted for months. Consequently, importers have warned that they will be forced to cease trading if nothing is done, which could have a severe impact on the market, as imports account for around two-thirds of drug expenditure.

Nevertheless, the Romanian pharmaceutical market is increasingly being targeted by Indian generics markers. In March 2008, India-based Glenmark Pharmaceuticals established a new subsidiary in Romania, Glenmark Pharmaceuticals s.r.l, boosting its presence in CEE to three countries in total. In the preceding months, Indian Lupin, Dr Reddy’s Laboratories and Shreya Lifesciences had been linked to a potential purchase of local generics producer LaborMed, following the lead of Ranbaxy, which now owns Terapia. However, the LaborMed Pharma Group was acquired by US investment fund Advent International, which is planning to modernise business processes, strengthen the company’s portfolio and brand image, as well as expand through local and regional acquisitions.

Key Topics Covered:

– Romania Pharmaceuticals And Healthcare Industry SWOT

– Romania Business Environment SWOT

– Pharmaceutical Business Environment Ratings

– Limits To Potential Returns

– Risks To Potential Returns

– Romania – Market Summary

– Regulatory Regime

– Recent Pricing And Reimbursement Developments

– Industry Developments

– Health Status

– Pharmaceutical Industry

– Domestic Industry Developments

– Foreign Industry Developments

– Medical Devices

– Patented Market Forecast

– Generics Market Forecast

– OTC Market Forecast

– Export/Import Forecasts

– Other Healthcare Data Forecasts

– Key Risks To BMI’s Forecast Scenario

– Competitive Landscape

– Our Forecast Modelling

Companies Mentioned:

– Actavis Romania (Sindan)

– Antibiotice Iasi

– GlaxoSmithKline (Europharm)

– Krka

– LaborMed Pharma

– Merck & Co

– Novartis

– Ozone Laboratories

– Pfizer

– Roche

– Sanofi-Aventis

– Terapia-Ranbaxy

– Zentiva (incorporating Sicomed)

For more information visit http://www.researchandmarkets.com/research/a4c187/romania_pharmaceut

Gore Wins Approval for Expanded Indication of Gore Viabahn Stent-Graft

W L Gore & Associates has received approval from the FDA to market the Gore Viabahn Endoprosthesis for use in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4-12mm.

The iliac indication was obtained using data collected as part of the Gore Viabahn Endoprosthesis feasibility study that was conducted in the US and Europe from 1996 to 1999. Data collected from this study was used to establish the Gore Viabahn Endoprosthesis as safe and effective for treatment of iliac arterial occlusive disease when used in accordance with its labeling.

The Gore Viabahn Endoprosthesis was previously approved for use in patients with symptomatic peripheral artery disease in superficial femoral artery (SFA) lesions with reference vessel diameters ranging from 47.5mm.

The Gore Viabahn Endoprosthesis is a stent-graft and is said to be the only device of its kind on the market and approved for treating peripheral vascular disease in the SFA.

Ovation Acquires Rights to Prestwick’s Huntington’s Drug

Ovation Pharmaceuticals has acquired from Prestwick Pharmaceuticals the exclusive license in the US to commercialize Xenazine, an orphan drug recently approved by the FDA for the treatment of chorea associated with Huntington’s disease. Financial terms of the deal were not disclosed.

Subsequently, Biovail, the Canadian pharmaceutical company, has acquired Prestwick. Under the terms of the agreement, Biovail and Ovation will jointly develop additional follow-on indications for Xenazine and related products in the US in conjunction with Cambridge Laboratories, the worldwide license holder of the drug.

Xenazine is the first and only FDA-approved treatment for any Huntington’s disease-related disorders. Ovation expects to launch the product in the US by the end of 2008.

Jeffrey Aronin, president and CEO of Ovation, said: “This drug represents a strong strategic fit and complements our existing portfolio of central nervous system products, in addition to continuing our business strategy of pursuing opportunities to bring important new medicines to severely ill patients with unmet medical needs.”

Del Monte Foods Sponsors American Heart Association’s 2008 Start! San Francisco Heart Walk

Del Monte Foods (DLM) announced today that it is the Presenting Sponsor of the American Heart Association Start! San Francisco Heart Walk 2008, which challenges San Franciscans to raise $1.5 million for the fight against heart disease and stroke. This year is Del Monte’s third year as a sponsor of the Walk.

“Del Monte Foods is committed to nourishing families and enriching lives every day, and we are proud to team up with the American Heart Association in the fight against heart disease,” said Richard G. Wolford, Chairman and Chief Executive Officer of Del Monte Foods. “We encourage consumers to get active every day, whether it’s a brisk walk with the whole family, including pets, or a lunch-time stroll during the workday. In addition, we at Del Monte recognize the busy lifestyles of today’s families and are pleased that many of our products offer great tasting, heart-healthy food choices that are nutritious and convenient.”

As the lead local sponsor of the Start! San Francisco Heart Walk, Del Monte will feature two booths at Justin Herman Plaza that will offer samples of a variety of great-tasting, nutritious products for Heart Walk participants and their four-legged friends. Attendees will receive samples of a variety of good-for-you products including Fruit Naturals(R) and Del Monte Lite(R) 100 Calorie Fruit, both of which are important sources of Vitamins A and C. And whether their furry friends are walking alongside them or waiting for them at home, walkers can also grab samples of Meow Mix(R) Wholesome Goodness(TM) cat food or Pup-Peroni(R)50 Calorie Snack Pouches for a dose of cat- and pup- friendly nutrition.

The Company will also be represented by nearly 200 Del Monte employees lacing up their sneakers to participate in the Heart Walk, which takes place just steps away from Del Monte’s San Francisco corporate headquarters. Through an internal digital-marketing campaign, Del Monte is encouraging its employees to pledge their support of the Heart Association’s efforts to raise $1.5 million.

Walking AND Eating your Way to a Healthy Heart

According to the American Heart Association, approximately one in three deaths are attributed to cardiovascular disease and an estimated 80 million people in the U.S. have one or more types of cardiovascular disease.

To help reduce the risk of heart disease, the Heart Association recommends a diet rich in fruits and vegetables, whole-grain, high-fiber foods, and encourages eating fish at least twice a week.

Del Monte offers a broad selection of nutrient-dense foods — including its fruits, vegetables, and tomatoes and offers families the ultimate in convenience, nutrition and year-round availability.

Get Healthy with Your Four-Legged Friend

The American Heart Association’s Start! movement promotes walking as an important part of a healthy lifestyle because walking has the lowest dropout rate of any physical activity, and is the simplest positive change individuals can make to effectively improve their heart health. Getting a daily workout is as easy as taking your dog for a brisk walk through the neighborhood. Let your furry friend lead the way and be sure to aim for at least a half-hour workout. The American Heart Association recommends moderate-to-vigorous-intensity physical activities for at least 30 minutes on most (and preferably all) days of the week.

And while walking is certainly great exercise, don’t forget about swimming, hiking, or playing catch in the yard or at the park with your pup. Exercising with a pet can be a great way to stick to your workout routine – it’s good for you and your pet.

About Del Monte Foods

Del Monte Foods is one of the country’s largest and most well-known producers, distributors and marketers of premium quality branded food and pet products for the U.S. retail market, generating more than $3.74 billion in net sales in fiscal 2008 (including sales generated by operations now classified as discontinued operations). With a powerful portfolio of brands including Del Monte(R), S&W(R), Contadina(R), College Inn(R), Meow Mix(R), Kibbles ‘n Bits, 9Lives(R), Milk-Bone(R), Pup-Peroni(R), Meaty Bone(R), Snausages(R) and Pounce(R), Del Monte products are found in nine out of ten U.S. households. The Company also produces, distributes and markets private label food and pet products. For more information on Del Monte Foods Company (NYSE: DLM) visit the Company’s website at www.delmonte.com.

Del Monte. Nourishing Families. Enriching Lives. Every Day.(TM)

Dr. Neil Gordon of Nationwide Better Health to Present New Findings on Lifestyle Health Coaching at AACVPR Annual Meeting

Nationwide Better Health(SM), a leading provider of health and productivity management solutions, announced today that its chief medical and science officer, Dr. Neil Gordon, will present his research entitled “Effect of a Lifestyle Health Coaching Program on Multiple Cardiovascular Disease Risk Factors in Participants with Classes I, II, and III Obesity” at the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) annual conference in Indianapolis, Ind. today, Sept. 19 and Saturday Sept. 20, between 10:30 – 11 a.m. Dr. Gordon will be available for questions and discussion during the session time noted, located in the Indianapolis Convention Center.

Despite unprecedented public attention, the obesity epidemic continues to plague the U.S., as rates of adult obesity now exceed 25 percent of the population in 19 states(1). Obesity is a major risk factor for cardiovascular disease. According to the American Heart Association, cardiovascular disease kills nearly 2,400 Americans each day. Moreover, the estimated direct and indirect cost of cardiovascular disease in the U.S. for 2008 is $448.5 billion.

In a landmark one-year study conducted with 3,613 adults with classes I, II and III obesity, Dr. Gordon et. al. demonstrated that obese individuals can significantly improve multiple cardiovascular disease risk factors by participating in a one-year lifestyle health coaching program.

When enrolled in the Nationwide Better Health lifestyle health coaching program, participants benefited from weight loss, reductions in blood pressure, cholesterol, triglycerides, blood glucose, and the overall chances of having a heart attack. The study shows that even individuals with severe obesity can derive substantial benefit from the program.

Dr. Gordon’s study serves to demonstrate the important role that a carefully structured, evidence-based lifestyle health coaching program can play in combating both the obesity and cardiovascular disease epidemics. The study’s findings have important implications for preventing unnecessary death and disability, enhancing productivity, and reducing rapidly escalating health care expenditures in the U.S.

To learn more about the Nationwide Better Health lifestyle health coaching program, visit http://www.nwbetterhealth.com/products-services/health-promotion.html.

About Nationwide Better Health

Nationwide Better Health(SM), a subsidiary of Nationwide(R), is a leading provider of health and productivity management solutions, aimed at improving the health and productivity of America’s workforce. Nationwide Better Health is the first company to truly integrate the best collection of health and productivity services available today, including health and wellness, and disease, disability, absence, medical and maternity management. The company’s offerings work together and independently to address both sides of the cost equation: increased efficiency of health and productivity programs and better employee health and well-being to reduce health care-related costs. For more information, call 866.404.6924 or visit: www.nwbetterhealth.com.

Nationwide, the Nationwide framemark and On Your Side are federally registered service marks of Nationwide Mutual Insurance Company. Nationwide Better Health is a service mark of Nationwide Mutual Insurance Company.

(1) Trust for America’s Health, 2007: F as in Fat: How Obesity Policies are Failing in America

Diabetes Discrimination: A New Headache for Employers

By Elsberry, Richard B

How do you deal with an employee who has his disease under control? THREE OF THE BIGGEST ONgoing regulatory challenges facing industrial employers are a requirement from the U.S. Occupational Safety and Health Administration to provide a safe workplace, the Environmental Protection Agency’s anti-pollution crusade, and the high cost of compulsory Workers’ Compensation insurance.

Now there is yet another human resources headache: the Americans With Disabilities Amendments Act, which is designed to eliminate judicial misinterpretation of the act’s original meaning and intent.

Soon to clear Congress, it will facilitate a surge in discrimination litigation targeted at firms who refuse to make reasonable workplace adjustments requested by disabled employees, or who have hiring or promotion policies that automatically reject otherwise qualified disabled applicants. The Americans with Disabilities Act, or ADA, is enforced by the Equal Employment Opportunity Commission, or EEOC.

The original intent of Congress when it passed ADA in 1990 was to protect an estimated 50 million Americans considered disabled by a dozen or more physical or mental impairments, such as epilepsy, HIV, MS, cancer, diabetes, MD, bipolar disorder, smf depression.

But in recent years federal courts have made many disabled persons subject to a Catch-22.

The Supreme Court, for example, ruled that a diabetic who has the dis ease under control with medications or diet is not disabled and therefore not covered under ADA. Yet because he is a diabetic he can be fired if the employer considers him a “direct threat” to the workplace because he might experience a hypoglycemic (low blood sugar) episode and pass out, causing the accident.

Other courts have ruled that a job candidate with Muscular Dystrophy was not disabled because he was able to perform the “major life activity” of brushing his own teeth, and that a fired mechanic with high blood pressure was not covered by the ADA because he had it under control with drugs.

These and other court rulings incensed many congressmen, who have struck back by introducing the ADA Amendments Act (HR 3195) to restore the original intent of the law. The restoration act was passed 402-17 in the House of Representatives on June 25. Confirmation in the Senate is expected this fall.

The bipartisan act clarifies the definition of disability, including what the phrase “substantially limited in a major activity” means. It also prohibits the consideration of “mitigating measures,” such as medication, and extends coverage to those who experience discrimination based on a perception of impairment, regardless of whether they actually have a disability.

ADA also prohibits an employer from firing or taking other action against an employee because he has a spouse, children, or relatives who require expensive, ongoing healthcare for disabilities.

The ADA applies only to firms with more than 15 employees, but many states also have comprehensive discrimination laws encompassing firms with as few as three employees.

The most widespread American disability is diabetes, which affects 24 million adult Americans, of which three million were diagnosed in the last two years. Diabetes is an incurable malady; it occurs when the pancreas stops producing the hormone insulin, which regulates bodily blood-sugar levels. To keep it in check requires regular monitoring and medication, and changes in lifestyle and diet.

Diabetes is spreading throughout the adult population faster than you can say Wilford Brimley. Thanks to an aging workforce, sedentary jobs, and rampant obesity, its incidence increased by 80% between 1996 and 2006, and current estimates are that another 41 million Americans are highly susceptible to this largely hereditary disease.

Many middle-aged workers find out they are candidates for diabetes when one of their parents is diagnosed as diabetic and has to start taking insulin and frequently monitoring glucose (bloodsugar) levels.

As diabetes is not an obvious disability, like a missing limb, chances are many firms already have diabetics on their payroll. They could be among the 17 million Americans successfully managing the illness, or they might be among the 7 million who have the disease but don’t yet realize it.

Employers need to be concerned about diabetes not only because of its potential for discrimination litigation, but also because it can affect on-the-job performance and increase healthcare costs. Average medical expenses of a diabetic are five times greater than for a non- diabetic-$13,243 versus $2,560. Employers also need to be aware that diabetes can cause hearing and visual impairment, which uncorrected could lead to a workplace accident.

Regardless of how the courts might interpret the restored ADA, it seems to be in the employer’s best interest to avoid costly confrontations and to try to improve productivity by working with the growing diabetic population, and those at risk for the disease. Some firms with successful diabetes prevention programs are General Electric Energy, Land’s End, Lockheed Martin, General Motors and the Dallas Federal Reserve Bank.

As diabetes is not an obvious disability, like a missing limb, chances are many firms already have diabetics on their payroll

By Richard B. Elsberry, EA Contributing Editor

Copyright Barks Publications Sep 2008

(c) 2008 Electrical Apparatus. Provided by ProQuest LLC. All rights Reserved.

Medicare Strike Force Indicts 18 Los Angeles Area Residents For Health Care Related Fraud

WASHINGTON, Sept. 18 /PRNewswire-USNewswire/ — Eighteen Los Angeles area residents have been charged in eight separate indictments for their roles in Medicare fraud schemes totaling more than $33 million, Acting Assistant Attorney General Matthew Friedrich of the Criminal Division and U.S. Attorney for the Central District of California Thomas P. O’Brien announced today.

Federal and state Medicare Fraud Strike Force (MFSF) agents arrested 18 people today in the greater Los Angeles area. Agents targeted durable medical equipment (DME) company owners, medical professionals and medical clinic owners who are alleged to have engaged in various schemes to defraud Medicare of $33,264,133 in fraudulent billing. The eight indictments in which the defendants are charged outline various types of fraud including schemes involving the fraudulent ordering of power wheelchairs, orthotics, hospital beds, enteral nutrition and feeding supplies. Enteral nutrition is sustenance ingested by patients through a feeding apparatus. In addition, federal agents began executing search warrants at six locations throughout Los Angeles County.

“Today’s arrests are the result of government agencies working together to proactively target those allegedly stealing taxpayer money,” said Acting Assistant Attorney General Matthew Friedrich. “For the more than 40 million Americans who rely on the Medicare program for health coverage, law enforcement efforts to bring those committing these frauds to justice as quickly as possible will also help protect the integrity of the program and taxpayer dollars.”

“Strike Force operations are a new weapon in federal law enforcement’s arsenal to protect American taxpayers from Medicare fraud,” said U.S. Attorney Thomas P. O’Brien. “With real-time access to Medicare claims data, law enforcement in Los Angeles is developing better tools to enhance our abilities to combat fraud in our community.”

“Any time false claims are submitted for payment, the nation’s health insurance programs suffer,” said Daniel Levinson, Inspector General of the Department of Health and Human Services. “OIG will continue to work closely with our law enforcement partners to identify any individuals who manipulate the system to illegally obtain crucial Medicare or Medicaid dollars.”

“Those who defraud the Medicaid and Medicare programs and private insurance companies increase the cost of health care for everyone,” said Salvador Hernandez, Assistant Director in Charge of the FBI in Los Angeles. “Career criminals and organized criminal groups have become involved in health care fraud in Southern California and across the country. The FBI is committed to rooting out scams and reclaiming money improperly paid out by government-sponsored programs and private insurers. The Strike Force affords us the necessary prosecutorial support to successfully address this multi-billion dollar crime problem.”

“The use of real-time Medicare claims data continues to help the Strike Force team members identify potential fraudulent activities in Southern California,” said Kerry Weems, acting Administrator of the Centers for Medicare and Medicaid Services (CMS). “With more than 10,000 active durable medical equipment suppliers in California, the Strike Force’s efforts are helping to protect Medicare and Medicare beneficiaries.”

The first indictment charges Armen Shagoyan, 38, Edward Aslanyan, 35, Carolyn A. Vasquez, 44, and Zurama C. Espana, 29, with conspiring to submit more than $16.3 million in Medicare claims for medically unnecessary power wheelchairs between April 2007 and June 2008 from medical clinics they owned in Los Angeles and Van Nuys. In addition to the clinics, Aslanyan and Shagoyan are charged with owning multiple DME companies that allegedly billed Medicare for unnecessary items. Shagoyan, Aslanyan, Vasquez and Espana are charged with one count of conspiracy to commit health care fraud. Shagoyan, Aslanyan and Vasquez are also charged with six counts of submitting false claims to the Medicare program. Espana is additionally charged with four counts of submitting false claims to the Medicare program. If convicted on all charged counts, Shagoyan, Aslanyan and Vasquez each face up to 65 years in prison, and Espana faces up to 45 years in prison.

The second indictment charges that Garnik Yesayan, 44, conspired to submit $6.9 million in fraudulent claims to Medicare for orthotic devices, motorized wheelchairs, hospital beds, enteral nutrition and feeding supply kits, diabetic shoes and other medical devices between January 2006 and November 2007. Yesayan is charged with one count of conspiracy to commit health care fraud and four counts of submitting false claims to the Medicare program. If convicted on all charged counts, Yesayan faces a maximum sentence of 45 years in prison.

The third indictment alleges that between November 2004 and September 2008, Elsie R. Edmond, 50, Marlon O. Palma, 37, Leslie V. Duarte, 22, Josue Gonzalez, 27, Kelechi Ajouku, 28, and Gloria C. Hernandez, 54, conspired to submit $2.3 million in fraudulent claims through a DME company called Santos Medical Supply to the Medicare program for medically unnecessary enteral nutrition and feeding supply kits, and motorized wheelchairs. Hernandez allegedly recruited patients as well as obtained false prescriptions and sold them to Santos. Edmond, Palma, Duarte, Gonzalez, Ajouku and Hernandez are charged with one count of conspiracy to commit health care fraud. Edmond, Palma, Gonzalez and Ajouku are also charged with 24 counts of submitting false claims to Medicare, Duarte with 16 counts of submitting false claims to Medicare and Hernandez with eight counts of submitting false claims to the Medicare. In addition, the indictment charges Edmond, Palma, Duarte, Gonzalez, Ajouku and Hernandez with one count of aggravated identify theft. If convicted, each defendant faces a mandatory minimum sentence of two years in prison. Edmond, Palma, Gonzalez and Ajouku each face a maximum sentence of 252 years in prison if convicted on all charged counts. If convicted on all charged counts, Duarte faces a maximum sentence of 252 years in prison and Hernandez faces a maximum sentence of 252 years in prison.

Teresa Bagdasarian, 52, is alleged in a fourth indictment to have conspired with others to file more than $1 million in false claims with Medicare between May 2006 and May 2008. Bagdasarian allegedly billed Medicare for unnecessary orthotic devices, wheelchairs, canes, walkers, hospital beds and heating implements. Bagdasarian is charged with one count of conspiracy to commit health care fraud and eight counts of health care fraud. If convicted on all charged counts, Bagdasarian faces a maximum 90 year prison sentence.

In a fifth indictment, between January 2006 and April 2007, Andranik Mirzoyan, 56, and Aram Mirzoyan, 21, are alleged to have conspired to submit approximately $1.8 million in false claims to Medicare for wheelchairs and other DME. The indictment alleges that Andranik Mirzoyan owned and controlled a DME company, while Aram Mirzoyan coordinated the deliveries of unneeded DME. They are charged with one count of conspiracy to commit health care fraud and four counts of health care fraud. If convicted on all counts, each faces a maximum sentence of 50 years in prison.

Levon Sedrakyan, 34, is charged in a separate sixth indictment with conspiring to submit $3.1 million in fraudulent claims to Medicare for orthotic devices, motorized wheelchairs, hospital beds, enteral nutrition and feeding supply kits, diabetic shoes and other medical devices. Sedrakyan allegedly used multiple companies that he placed in other individuals names to fraudulently bill Medicare. Sedrakyan is charged with one count of conspiracy, one count of conspiracy to commit health care fraud, four counts of submitting false claims to the Medicare program and one count of making false statements in a matter involving a health care benefit plan. If convicted on all charged counts, Sedrakyan faces a maximum sentence of 60 years in prison.

Andrews Asante, 53, is alleged in another indictment to have conspired to file more than half a million dollars in false claims to Medicare between June 2005 and April 2006. Asante is charged with billing for unnecessary and undelivered orthotic devices, motorized wheelchairs, hospital beds, enteral nutrition and feeding supply kits, and diabetic shoes. Asante is charged with one count of conspiracy to commit health care fraud. If convicted, he faces a maximum sentence of 15 years in prison.

Finally, in a superseding indictment, Ronald L. Bradshaw and Anna Vasilyan were charged with conspiring to file more than $1.5 million in false claims to Medicare. The indictment charges that Vasilyan paid patient recruiters to bring beneficiaries to a clinic where Bradshaw, a physician’s assistant, allegedly prescribed unnecessary medical equipment. Bradshaw and Vasilyan are charged with one count of conspiracy to commit health care fraud and 10 counts of submitting false claims to the Medicare program. If convicted on all charged counts, each faces a maximum sentence of 110 years in prison.

These cases are a result of the operations by MFSF, a multi-agency team of federal, state and local prosecutors and agents designed specifically to combat Medicare fraud. Strike force operations began in the Los Angeles area on March 1, 2008.

The cases are being prosecuted by Trial Attorneys Jonathan Baum, Steven Kim, Joseph C. Hudzik, Cristina M. Moreno and Jeremy M. Kirkland of the Criminal Division’s Fraud Section, and Assistant U.S. Attorneys Margaret L. Carter, April A. Christine and Christopher Lui of the U.S. Attorney’s Office. The cases were investigated by the FBI; the Department of Health and Human Services, Office of the Inspector General; CMS; the California Department of Justice; the Bureau of Medical Fraud and Elder Abuse; and the Los Angeles County Health Authority Law Enforcement Task Force. The Strike Force is led by Kirk Ogrosky, Deputy Chief of the Criminal Division’s Fraud Section in Washington, D.C., and the office of U.S. Attorney Thomas P. O’Brien of the Central District of California. Since the inception of MFSF operations in 2007, federal prosecutors have indicted 103 cases with 175 defendants in both Los Angeles and Miami. Collectively, these defendants fraudulently billed the Medicare program for more than half a billion dollars.

An indictment is merely an allegation and defendants are presumed innocent until and unless proven guilty.

U.S. Department of Justice

CONTACT: U.S. Department of Justice Office of Public Affairs,+1-202-514-2007, TDD +1-202-514-1888

Web Site: http://www.usdoj.gov/

What Does It Feel Like When God Heals? — A Collection of Uplifting Stories About the Power of Prayer

COLUMBIA, S.C., Sept. 18, 2008 (GLOBE NEWSWIRE) — In a study of divine healing funded by The Centers for Disease Control, Jane Teas, Ph.D., Melinda Holland, and Georgianna Jackson found that God and prayer are not merely coping mechanisms for pain and suffering; these researchers discovered what the raw power of the Lord feels like. From over a hundred interviews with Christians in South Carolina, they compiled the best narratives in one remarkable collection, Faith that Heals: Stories of God’s Love.

These first person narratives of divine healings are about finding wholeness in our fragmented world. Beyond physical health, these healings are about finding “the peace that passeth all understanding.” Some people just asked for God’s help, like the man’s silent prayers to survive a kidnapping; a mother speaking in tongues to plead for her baby’s life; or a church unified in prayer for healing the birth defects of a newborn baby. Other times God found man, whether in the unexpected jolt of energy from being slain in the spirit, or as a voice of benediction heard in the heart. These are real stories from real people with real successes.

These Stories of God’s Love are spiritual powerhouses of strength and give testimony of God’s continual presence and love in our lives. Most of all, we learn more about who God is from 44 new personal points of truth. This is a book to treasure and share.

For more information, log on to www.Xlibris.com.

About the Author

H. Jane Teas, Ph.D., is a researcher at the University of South Carolina. She studies Complementary and Alternative Medicine.

Melinda (Mindy) Holland holds a Master’s Degree in Ministerial Studies from the Lutheran Theological Seminary at Gettysburg, Pennsylvania. She is a consecrated Diaconal Minister of the Evangelical Lutheran Church in America.

Tara Georgianna Jackson is a graduate of the University of South Carolina with a degree in English. She is a born-again Christian.

Virginia Strazdins received her M.F.A. from the University of Colorado. Her work grows out of a deep respect for the natural world and the inspiration it provides.

                     Faith that Heals * by H. Jane Teas, Ph.D.                      Publication Date: February 25, 2008          Trade Paperback; $19.99; 250 pages; ISBN 978-1-4257-9189-6           Cloth Hardback; $29.99; 250 pages; ISBN 978-1-4257-9192-6 

To request a complimentary paperback review copy, contact the publisher at (888) 795-4274 x. 7836. Tear sheets may be sent by regular or electronic mail to Marketing Services. To purchase copies of the book for resale, please fax Xlibris at (610) 915-0294 or call (888) 795-4274 x.7876.

Xlibris books can be purchased at Xlibris bookstore. For more information, contact Xlibris at (888) 795-4274 or on the web at www.Xlibris.com.

This news release was distributed by GlobeNewswire, www.globenewswire.com

 CONTACT:  Xlibris           Marketing Services           (888) 795-4274 x. 7876           [email protected]