Yale Researchers Named Ellison Foundation Senior Scholars In Aging

Two distinguished Yale scientists have been named Senior Scholars in Aging research by the Ellison Medical Foundation, a four-year award made to established investigators for research into understanding development processes that affect lifespan, and age-related diseases and disabilities.

Named at Yale are Frank J. Slack, associate professor of molecular, cellular and Developmental biology, and Sandra L. Wolin, professor of cell biology and of molecular biophysics & biochemistry.

Frank Slack studies the genetic switches that control development, and “aging” as a developmental process. According to Slack, “Changes in gene expression in aged adults – across many species – do not solely seem to be a response to mounting cellular damage. Rather, a conserved, developmentally-timed regulation of gene activity during young adulthood seems to control features of aging.”

Past research on C. elegans and Drosophila, laboratory round worms and fruit flies, demonstrated that in early adulthood these animals turn off a conserved group of genes that mobilize energy from food, and turn on stress response genes. There is a similar trend in human brain tissue, where the switch occurs at around age 40, implying that aging, or specifically the time of death, is under a timed control at the genetic level.

“We found that genes that regulate the timing of events during C. elegans development also regulate timing of aging and death during adulthood,” said Slack. Consistent with the lifespan analysis, mutants he studied were stress-sensitive and aged prematurely. Since some of these genes coded for small non-coding RNAs called microRNAs, his work provided some of the best evidence for a novel role for microRNAs in aging, and opened the potential of using microRNAs to regulate human health during aging.

Slack joined the Yale faculty in 2000 after completing his undergraduate work in microbiology, biochemistry and molecular genetics at the University of Cape Town, his doctoral work in molecular biology at Tufts University and post-doctoral training at Stanford University School of Medicine and Harvard University. He is also a member of the Yale Cancer Center.

Sandra Wolin will determine how RNA damage that occurs because of normal cellular activity contributes to aging. She is studying how RNA molecules fold into intricate structures inside cells and how cells recognize misfolded RNAs. “In both mammalian cells and yeast, we focus on proteins and RNA-protein complexes that play critical roles in these processes,” said Wolin. “Our work has revealed unexpected connections between RNA misfolding, radiation damage repair and autoimmune disease.”

Damaged RNAs have often been detected in the brains of aging animals and patients with neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease. However, because the cellular pathways for recognizing and degrading these RNAs are unknown, it has not been possible to determine whether RNA damage contributes to aging or to age-related diseases. Under this program, Wolin will identify genes involved in detecting and degrading damaged RNAs and determine whether they contribute to senescence.

“Once we have identified these important genes in yeast, we will determine whether the same components are involved in this process in mouse and human cells,” said Wolin. “We will also determine whether the failure to degrade damaged RNAs contributes to senescence in mouse and human cells. Knowing how RNA damage contributes to aging or to neurodegeneration could be of broad importance for designing therapeutics that slow the aging process.”

Wolin joined the Yale faculty in 1991. After undergraduate work in biochemistry at Princeton University, she received both an M.D. degree and a Ph.D. in molecular biophysics and biochemistry from Yale University, and then completed her postdoctoral training at the University of California, San Francisco. She is also a member of the Yale Cancer Center.

The Ellison Medical Foundation Senior Scholar program in Aging brings an award of $150,000 per year over the four years to support established investigators in the development of new and creative research programs.

According to Executive Director Richard L. Sprott, “The Ellison Medical Foundation’s goal is to provide scientists with the resources, freedom, and flexibility to pursue high-risk research that could have a scientific impact worldwide. The Foundation expects that its programs will stimulate exciting innovative research that will improve lives and influence future discoveries.”


Contact: Janet Rettig Emanuel

Yale University

Tobacco Company Sues Washington Over Ban On Cigarette Promotions To Adult Smokers

R.J. Reynolds
Tobacco Company today filed suit in U.S. District Court for the Western
District of Washington (Tacoma Division) to overturn a recently enacted
state law prohibiting tobacco companies from sampling products to adult
smokers in bars, nightclubs and other adult-only venues.

In its court filing, R.J. Reynolds contends the new law, approved by
Gov. Gregoire on March 9, violates the First Amendment and is preempted by
the Federal Cigarette Labeling and Advertising Act, the federal law that
bars states from regulating cigarette advertising and promotion.

“The new law says that its purpose is to protect minors, but Washington
law already prohibits cigarette sampling where minors may be present,” says
Darryl R. Marsch, senior counsel for R.J. Reynolds. “The new law is an
unconstitutional attempt to prevent us from using an accepted form of
product promotion with adult smokers.”

Marsch notes the Supreme Court has held that product sampling is a form
of communication protected by the First Amendment, and federal courts have
ruled that cigarette sampling bans are preempted by federal law.

R.J. Reynolds says in its filing that forms of cigarette advertising
and promotion are sharply restricted by the Master Settlement Agreement
(MSA). However, the MSA does not bar sampling in adult-only venues.
“Sampling in adult-only facilities is an effective and responsible way
for us to communicate with adult smokers,” Marsch says.

The new law is due to take effect on June 7. R.J. Reynolds will ask the
federal court for a hearing on its lawsuit before that date.

R.J. Reynolds Tobacco Company, an indirect subsidiary of Reynolds
American Inc. (NYSE: RAI), is the second-largest tobacco company in the
United States, manufacturing about one of every three cigarettes sold in
the country. The company’s brands include five of the 10 best-selling U.S.
cigarette brands: Camel, Kool, Winston, Salem and Doral.


Higher Cigarette Taxes Don’t Deter All Smokers, Canada

Raising taxes on cigarettes, a public health measure used by governments to encourage people to quit, doesn’t motivate all smokers to stop the deadly habit. A study on the long-term impact of taxing cigarettes, led by two Concordia University economists and published in the International Journal of Environmental Research and Public Health, found higher taxes do prompt low-and middle-income earners to quit. Yet price increases don’t persuade wealthier smokers or those aged 25 to 44 to butt out.

“Contrary to most studies, we find that the middle-aged group, which constitutes the largest fraction of smokers in our sample, is largely unresponsive to taxes,” says first author Sunday Azagba, a PhD candidate in the Concordia Department of Economics. “While cigarette taxes remain popular with policy-makers as a key anti-smoking measure, their effectiveness largely depends on how people respond to them.”

The research team examined data collected by Statistics Canada, specifically the National Population Health Survey conducted from 1998-99 to 2008-09. They analyzed three categories of daily smokers: People aged 12 to 24, 25 to 44 and 45 to 65.

A conventional belief among policy makers is that higher cigarette prices will reduce smoking among target populations such as high school students. “Overall, it was smokers from lower socioeconomic groups who are more price-responsive than those from higher socioeconomic groups,” says co-author Mesbah Sharaf, a PhD candidate in the Concordia Department of Economics. “If there is a 10 per cent increase in taxes then smoking participation will fall by about 2.3 per cent.”

The research team also found people with post-secondary education were less likely to smoke than those with less than high school education. “If smokers are sophisticated about their self-control and responsive to prices, taxes could act as a self-control incentive for them,” says Azagba. “Higher taxes for some people, when consumption of addictive goods is driven by cues, may be counterproductive.”

Canadian smokers, international picture

The substantial social, economic and health costs caused by tobacco use have led many countries to adopt higher cigarette taxes as a policy to reduce smoking. The World Health Organization estimates five million people around the globe die each year due to smoking-related illnesses and forecasts such deaths will increase to eight million people annually by 2030.

In Canada, cigarettes are taxed by both the federal, provincial and territorial governments. While smoking rates in Canada have been declining for more than two decades, says Azagba, “The lowest percentage of smokers can be found among women who are married, older, with high income and more education.”

About the study:
The paper, “Cigarette Taxes and Smoking Participation: Evidence from Recent Tax Increases in Canada,” published in the International Journal of Environmental Research and Public Health, was co-authored by Sunday Azagba and Mesbah Sharaf of Concordia University.


Concordia University

Fresenius Medical Care Introduces 2008T Hemodialysis Delivery System In North America

Fresenius Medical Care AG & Co. KGaA (Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world’s largest provider of dialysis products and services, yesterday introduced the 2008T, a smart-platform dialysis system featuring Fresenius Clinical Data Exchange® (CDX) software, at the American Society of Nephrology’s 43rd Annual Meeting and Scientific Exposition in Denver, Colorado. The groundbreaking technology is the first fully integrated dialysis therapy and management information system on the market and was developed to help physicians and clinic operators adjust to the new bundled payment environment due to take effect in the United States in January 2011. Available immediately, the 2008T currently is scheduled to be marketed in North America and is cleared for use in the USA and Canada by the U.S. Food and Drug Administration and Health Canada.

The 2008T combines the company’s most advanced hemodialysis delivery system with Fresenius Clinical Data Exchange® (CDX) to provide caregivers, for the first time, chairside access to both dialysis treatment and medical information system (MIS) data to facilitate real-time adjustments to therapy and care plans. The platform accommodates MIS software from third-party vendors as well as the company’s proprietary systems, providing immediate access to all dialysis treatment and clinical trending data traditionally held in multiple locations. This integrated approach streamlines workflow and maximizes data collection for comprehensive billing.

The 2008T was developed in close association with the Renal Research Institute, one of the pre-eminent research institutions in the United States focused on improving the clinical care and quality of life of patients with chronic kidney disease.


Fresenius Medical Care

Multi-Center Study Concludes Nephros Mid-Dilution Hemodiafiltration Therapy Achieves Higher Clearance Of Low Molecular Weight Proteins

Nephros, Inc. (Amex: NEP),
announced today that the results of a randomized, multi-site scientific
study indicate that the Company’s Mid-Dilution Hemodiafiltration (Mid-HDF)
therapy, using its OLpur MD 190 filter, offers the advantages of both pre-
and post- HDF, and is “the most efficient dialysis procedure for
Low-Molecular Weight Protein removal.”

The study, conducted over a six-month period at seven European dialysis
centers, enrolled a total of 44 patients in Germany, France and Sweden.
Patients were put through 4-week wash-in and wash-out periods of
conventional high-flux hemodialysis using ultrapure dialysate to establish
the study’s baseline. Patients were then randomized to either Nephros’
Mid-dilution HDF therapy (20 patients) or standard Post-dilution HDF (24
patients). The study monitored three low-molecular weight protein
substances that generally accumulate as uremic toxins in patients treated
with conventional hemodialysis: Beta-2-microglobulin (b2m), Cystatin-C
(cyc), and Retinol- binding protein (rbp). By week 8 of the study’s test
period patients randomized to the Mid-dilution HDF therapy showed a
favorable decrease in all three LMW proteins. Compared to Post-dilution
HDF, patients using the Mid- dilution HDF therapy showed a lower trend of
b2m and cyc at week 8, and a similar result for rbp at week 12.

Entitled “Long-Term Multi-Center Trial Comparing Post- to Mid-Dilution
Online HDF: Effects on Low-Molecular Weight (LMW) Proteins,” the study was
led by Professor Bernard Canaud M.D. (University Hospital, Montpellier,
France) and Detlef Krieter M.D. (Nephrology, University Hospital, Wurzburg,
Germany and a member of the Nephros Scientific Advisory Board). Grant
research support was provided by Nephros.

“Mid-dilution HDF with the Nephros MD filter is a very promising tool
for optimizing renal replacement therapy in End Stage Renal Disease
patients. Compared to standard dialysis procedures, it is much more
efficient, and more effectively removes larger uremic toxins. This therapy
has the potential to improve the quality of life, reduce morbidity rates,
and ultimately reduce mortality risk for our patients,” said Dr. Krieter.

An abstract of the study was submitted to the American Society of
Nephrology (“ASN”) and was selected by its Program Committee to present the
results of the study on November 17th in a Poster Session at the ASN Renal
Week in San Diego, California.

In a recent publication by AK Cheung, et. al. in the Journal, American
Society of Nephrology (2006; 17: 546-555), pre-dialysis levels of beta-2-
microglobulin (b2m) have been shown to correlate with patient mortality;
this is based on the NIH-sponsored HEMO study of U.S. patients completed in
2002. Patients with pre-dialysis b2m levels between 42.5 and 50 mg/L showed
a 60% higher relative risk of mortality compared to patients having
pre-dialysis b2m levels below 27.5 mg/L. “If we consider the mean
pre-dialysis level of beta-2- microbulin for patients in the HEMO study, at
37.3 mg/L, as being representative of the U.S. dialysis population, we have
the potential to significantly improve the mortality statistic for this
patient group once Nephros Mid-dilution HDF therapy is approved for use in
the U.S.,” stated Norman Barta, President & CEO of Nephros Inc.

About Nephros Inc.

Nephros, Inc., headquartered in New York, is a medical device company
developing and marketing products designed to improve the quality of life
for the End-Stage Renal Disease (ESRD) patient, while addressing the
critical financial and clinical needs of the care provider. ESRD is a
disease state characterized by the irreversible loss of kidney function.
Nephros believes that its products, particularly its Mid-Dilution
Hemodiafiltration therapy, are designed to remove a range of harmful
substances more effectively, and more cost-effectively, than existing ESRD
treatment methods; particularly with respect to substances known
collectively as “middle molecules,” due to their molecular weight, that
have been found to contribute to such conditions as dialysis related
amyloidosis, carpal tunnel syndrome, degenerative bone disease and
ultimately, to mortality in the ESRD patient.

Nephros also markets a line of water filtration products, the Dual
Stage Ultrafilter (DSU). The Company’s patented dual stage cold
sterilization ultrafilter has the capability to filter out bacteria and,
due to its exceptional filtration levels, filter out many viruses and
parasites. The DSU proprietary design provides dual stage filtration which
virtually eliminates the risk of filtration failure. The Company considers
the DSU a significant breakthrough in providing affordable and reliable
water filtration. The DSU is based on Nephros’ proprietary water filtration
technology originally designed for medical use in its H2H machine, and is a
complimentary product line to the Company’s main focus, the End Stage Renal
Disease therapy business.

For more information on Nephros please visit the Company’s website,

Forward Looking Statements

This news release contains certain “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995, as
amended. Such statements may include statements regarding the efficacy and
intended use of Nephros’s technologies, the timelines for bringing such
products to market and the availability of funding sources for continued
development of such products and other statements that are not historical
facts, including statements which may be preceded by the words “intends,”
“may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,”
“estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. For
such statements, Nephros claims the protection of the Private Securities
Litigation Reform Act of 1995.

Forward-looking statements are not guarantees of future performance,
are based on certain assumptions and are subject to various known and
unknown risks and uncertainties, many of which are beyond the control of
Nephros. Actual results may differ materially from the expectations
contained in the forward-looking statements. Factors that may cause such
differences include the risks that: (i) products, including the DSU
technology, that appeared promising to Nephros in research or clinical
trials may not demonstrate anticipated efficacy, safety or cost savings in
subsequent pre-clinical or clinical trials; (ii) Nephros may not obtain
appropriate or necessary governmental approvals to achieve its business
plan or effectively market its products; (iii) product orders may be
cancelled, patients or customers currently using Nephros’s products may
cease to do so and patients or customers expected to begin using Nephros’s
products may not do so; (iv) Nephros’s technology and products, including
DSU technology, may not be accepted in current or future target markets,
which could lead to the failure to achieve market penetration of Nephros’s
products; (v) Nephros may not be able to sell its ESRD or water filtration
products at competitive prices or profitably; (vi) Nephros may not be able
to secure or enforce adequate legal protection, including patent
protection, for its products; (vii) Nephros’ water filtration device and
technology, including its ability to remove a broad range of bacteria,
viral agents and toxic substances, may not achieve expected reliability,
performance and endurance standards; (viii) Nephros’ water filtration
technology may not achieve anticipated market acceptance, including among
hospitals, or that such technology may not be suitable for other
commercial, industrial or retail opportunities; and (ix) Nephros may be
unsuccessful in devising a practicable plan of action to timely regain
compliance with the AMEX listing standards. More detailed information about
Nephros and the risk factors that may affect the realization of forward-
looking statements is set forth in Nephros’s filings with the Securities
and Exchange Commission, including Nephros’s Annual Report on Form 10-KSB
filed with the SEC for the fiscal year ended December 31, 2005 and its
Quarterly Report on Form 10-QSB filed with the SEC for the fiscal quarter
ended June 30, 2006. Investors and security holders are urged to read those
documents free of charge on the SEC’s web site at sec. Nephros does
not undertake to publicly update or revise its forward-looking statements
as a result of new information, future events or otherwise.

Nephros, Inc

Neurogen Commences Sleep Maintenance Phase II Clinical Trial In Chronic Insomnia

Neurogen Corporation
(Nasdaq: NRGN) today announced that it has commenced a Phase II clinical
trial in chronic insomnia patients with the Company’s insomnia agent,
NG2-73. The study will measure sleep maintenance, as well as onset, across
a range of doses and formulations. This is one of two ongoing studies
designed to measure sleep onset and maintenance in patients with chronic
insomnia and this study complements the earlier Phase II clinical trial the
Company announced on October 30, 2006.

The Phase II clinical trial announced today is a randomized,
double-blind, placebo-controlled, multi-center, cross-over study designed
to determine the efficacy and safety of eight different dose and
formulation profiles of NG2-73 compared to placebo. The primary endpoint
will be wake after sleep onset (WASO). In addition, sleep onset, as
measured by latency to persistent sleep (LPS) and additional measures of
sleep maintenance will be explored in several secondary endpoints. At least
36 patients with chronic insomnia, aged up to 64 years, are expected to
participate in the study. Each patient will be randomly assigned to a
treatment sequence of study drug and placebo. Polysomnography will be used
to objectively measure various sleep parameters.

The study will test doses and sustained release formulations of NG2-73,
which are expected to span the projected therapeutic range. The
exposure/response relationships will also be examined and
pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilized to
facilitate dose and formulation optimization.

William H. Koster, President and CEO, said, “Our target product profile
for NG2-73 is a drug that provides rapid sleep onset and reduces wake time
through the night, with patients awakening feeling refreshed and with no
hangover effects. We saw dramatic results for rapid sleep onset in our
Phase II transient insomnia study. In these concurrent Phase II studies, we
are now testing our drug in chronic insomnia patients with sleep initiation
and sleep maintenance issues, since people with insomnia may suffer from
both. The clinical trial announced in October is a parallel design study
and is larger, with sleep onset as its primary endpoint. In this second
study, which is a cross-over design, we are primarily assessing sleep
maintenance effects for NG2-73.”

About Neurogen’s Insomnia Program

Neurogen previously announced results from Phase II human testing in
transient insomnia for NG2-73. The primary endpoint of the study measured
the efficacy of NG2-73 in reducing time to onset of persistent sleep in a
well established clinical model of transient insomnia in healthy adults. In
the multi-center, 369 subject study, NG2-73 was shown to significantly
reduce time to onset of persistent sleep versus placebo at all doses
tested. NG2-73 was well-tolerated at all doses, with no drug-related
serious adverse events or drug-related subject withdrawals.

Many prescription drugs approved for treatment of both onset and
maintenance symptoms of insomnia work by modulating the gamma-aminobutyric
acid (GABA) system of neurotransmitters. GABA is a chemical naturally
released in certain parts of the brain in order to inhibit brain activity.
Preclinical studies suggest that NG2-73 is pharmacologically distinct from
currently marketed insomnia agents, as well as those in development,
preferentially modulating alpha-3 receptor subtypes of the GABA-A
neurotransmitter system.

Helpful websites for information on insomnia:

National Sleep Foundation sleepfoundation
National Institutes of Health nih

About Neurogen Corporation

Neurogen Corporation is a drug discovery and development company
focusing on small molecule drugs to improve the lives of patients suffering
from disorders with significant unmet medical need, including insomnia,
Parkinson’s disease and restless legs syndrome (RLS), pain, depression, and
obesity. Neurogen conducts its research and development independently and,
when advantageous, collaborates with world-class pharmaceutical companies
to access additional resources and expertise.

Safe Harbor Statement

The information in this press release contains certain forward-looking
statements, made pursuant to applicable securities laws, that involve risks
and uncertainties as detailed from time to time in Neurogen’s SEC filings,
including its most recent 10-K. Such forward-looking statements relate to
events or developments that we expect or anticipate will occur in the
future and include, but are not limited to, statements that are not
historical facts relating to the timing and occurrence of anticipated
clinical trials, and potential collaborations or extensions of existing
collaborations. Actual results may differ materially from such
forward-looking statements as a result of various factors, including, but
not limited to, risks associated with the inherent uncertainty of drug
research and development, difficulties or delays in development, testing,
regulatory approval, production and marketing of any of the Company’s drug
candidates, adverse side effects or inadequate therapeutic efficacy or
pharmacokinetic properties of the Company’s drug candidates or other
properties of drug candidates which could make them unattractive for
commercialization, advancement of competitive products, dependence on
corporate partners, the Company’s ability to retain key employees,
sufficiency of cash to fund the Company’s planned operations and patent,
product liability and third party reimbursement risks associated with the
pharmaceutical industry. For such statements, Neurogen claims the
protection of applicable laws. Future results may also differ from
previously reported results. For example, positive results or safety and
tolerability in one clinical study provides no assurance that this will be
true in future studies. Neurogen disclaims any intent and does not assume
any obligation to update these forward-looking statements, other than as
may be required under applicable law.

Neurogen Corporation

NewYork-Presbyterian Performs Lifesaving Liver Transplant On Premature Infant

A 5-month-old New York infant received a lifesaving liver transplant for advanced liver failure diagnosed following her birth 10 weeks premature. One of the smallest babies ever to successfully receive a liver transplant, she weighed 4 pounds at the time of the surgery.

The surgery was performed in February and was led by Dr. Tomoaki Kato, surgical director of liver and intestine transplant programs at NewYork-Presbyterian Hospital/Columbia University Medical Center, and chief of abdominal organ transplantation and professor of surgery at Columbia University College of Physicians and Surgeons.

“Performing a transplant in a premature infant this size is a major challenge where any technical issue would have been fatal, but it was the only option,” says Dr. Kato. “Most babies born with her condition would not have the chance to grow up. This surgery shows that transplantation is possible — although only at an academic medical center with appropriate resources and only with focused teamwork and dedication.”

In the weeks after being born on Dec. 3, the patient was referred to NewYork-Presbyterian/Morgan Stanley Children’s Hospital where she was diagnosed with an irreversible liver injury of unknown origin. Cared for in the neonatal intensive care unit, she was on a ventilator and had dangerous fluid buildup in her abdomen and difficulty feeding. After being on the organ waitlist for two weeks, a replacement liver became available in Florida.

“The donor organ wasn’t a matching blood type and it was substantially larger than her diseased organ, but it was critical that we proceed. To accommodate its size we created an artificial abdominal wall using a Gore-Tex mesh,” explains Dr. Kato. “Unlike other organs, the liver has the unique ability to adapt itself to the patient’s body. In this case the organ is making itself smaller. As she grows, her new liver will grow with her.”

In the weeks following the surgery, the patient started recognizing her mother and responding to her by smiling. The child has also gained the ability to get nutrition through a feeding tube rather than intravenously. Her liver function normalized, and soon after the Gore-Tex mesh was removed and her abdomen closed.

Her medical care has been overseen by Dr. Steven Lobritto, medical director of pediatric liver transplantation at NewYork-Presbyterian/Morgan Stanley Children’s Hospital and associate clinical professor of pediatrics and medicine at Columbia University College of Physicians and Surgeons.

“While she is on immunosuppressant medication and received a blood-type mismatched organ, rejection is usually not a major issue in babies, whose bodies can more easily accept an organ than someone who is full grown,” says Dr. Lobritto.

Collaboration With the Neonatal Intensive Care Unit

According to Drs. Kato and Lobritto, the success of this transplant was a direct result of a novel transplant collaboration with the neonatal intensive care unit.

The patient’s tiny size and medical issues related to prematurity meant that she may not have received optimal treatment in the pediatric intensive care unit, where childhood transplant patients are normally treated. “Accommodating the patient in a NICU setting required thorough on-the-spot training for clinicians and caregivers at every level,” says Dr. Lobritto.

Dr. Ulana Sanocka, the neonatologist in charge of caring for this transplanted child at NewYork-Presbyterian/Morgan Stanley Children’s Hospital and an associate clinical professor of pediatrics at Columbia University College of Physicians and Surgeons, says: “It was a very rewarding collaborative experience. Everyone worked around the clock to ensure she received the best care possible.”

Special Note to the Media: NewYork-Presbyterian physicians and surgeons are available for interviews about the surgical procedure. At the parents’ request, the patient is not available for media interviews.

Organ Transplantation at NewYork-Presbyterian Hospital

The organ transplantation program at NewYork-Presbyterian Hospital — which includes NewYork-Presbyterian Hospital/Weill Cornell, NewYork-Presbyterian Hospital/Columbia and The Rogosin Institute — is the most active program of its kind in the nation, offering comprehensive and personalized care for the heart, liver, pancreas, kidney and lung. With outcomes ranked among the nation’s best, the Hospital is dedicated to improving quality of life for its patients. NewYork-Presbyterian’s dedicated teams of surgeons and physicians are responsible for many significant advances made over the past several decades in transplant surgery and the maintenance of healthy organs. The Hospital has been on the forefront of developing and improving anti-rejection medications (immunosuppressants), minimally invasive surgery for living donors, genetic methods to detect transplant rejection, strategies to increase opportunities for donor matching, islet cell transplantation, and the FDA-approved Left Ventricle Assist Device (LVAD) that functions as a bridge to transplantation for those waiting for a new heart.

NewYork-Presbyterian/Morgan Stanley Children’s Hospital

NewYork-Presbyterian/Morgan Stanley Children’s Hospital, located in New York City, offers the best available care in every area of pediatrics — including the most complex neonatal and critical care, and all areas of pediatric subspecialties — in a family-friendly and technologically advanced setting. Building a reputation for more than a century as one of the nation’s premier children’s hospitals, Morgan Stanley Children’s Hospital is affiliated with the Department of Pediatrics at Columbia University College of Physicians and Surgeons, and is Manhattan’s only hospital dedicated solely to the care of children and one of the largest providers of children’s health services in the tri-state area with a long-standing commitment to its community. It is also a major international referral center, meeting the special needs of children from infancy through adolescence worldwide. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report.

Source: NewYork-Presbyterian Hospital

FDA Approves FRAGMIN(R) As First Low-Molecular-Weight Heparin For Extended Treatment To Reduce The Recurrence Of Blood Clots In Patients With Cancer

The U.S. Food and Drug Administration (FDA) has approved a new indication
for FRAGMIN(R) (dalteparin sodium injection), for the extended treatment of
symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis
(DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in
patients with cancer.

VTE is the formation of a blood clot that can travel from a leg vein to
the lung, with potentially fatal results. FRAGMIN is the first
low-molecular- weight heparin (LMWH) approved in the U.S. for the extended
treatment of recurrent VTE in patients with cancer.

“Cancer treatments and the disease itself put this patient population
at significantly higher risk than non-cancer patients for developing DVT or
PE, the two conditions described as VTE,” said Frederick Rickles, MD, FACP,
clinical professor of medicine at George Washington University Medical

VTE is a frequent medical complication for patients with cancer.
Patients with cancer have an increased risk of VTE compared to those
without cancer. Additionally, patients with cancer may be immobilized,
which predisposes the patient to this condition.

Today’s FDA approval is based on data from the CLOT study, which
evaluated the safety and efficacy of FRAGMIN in reducing the recurrence of
DVT/PE in patients with cancer, compared to an oral anticoagulant. Patients
diagnosed with acute DVT, PE or both were randomized into two groups of 338
patients each. One group received FRAGMIN for six months. The other group
received FRAGMIN for five to seven days, followed by warfarin for six
months. Warfarin is an oral anticoagulant that has been used for many years
as the standard drug in the long-term treatment of VTE.

The CLOT study showed that, during a six-month period, nearly twice as
many patients (53) treated with warfarin experienced at least one episode
of DVT or PE compared to those treated with a once-daily administration of
FRAGMIN (27). Most of the difference occurred during the first month of
treatment. The benefit was maintained over the six-month study period.
Mortality rates were similar between the study groups at the end of the
study. The safety findings were numerically higher for the FRAGMIN group
versus the warfarin group for major bleeding, thrombocytopenia (drop in
platelet count) and liver enzyme elevations. Results from the CLOT study
were published in the July 10, 2003 issue of the New England Journal of

“The CLOT study provides clinical evidence that FRAGMIN is more
effective than traditional oral anticoagulant therapy in reducing risk of
recurrent VTE in patients with cancer,” said Dr. Rickles. “Physicians now
have an FDA- approved low-molecular-weight heparin specifically for
extended treatment to reduce the recurrence of blood clots in patients with

Eisai licensed exclusive U.S. rights to promote FRAGMIN from Pfizer Inc
in September 2005, and has assumed responsibility for product distribution.
This agreement for FRAGMIN is aimed at strengthening Eisai’s position in
oncology and critical care in the United States. Eisai and Pfizer currently
have three product alliances.

Additional Indications

In the United States, FRAGMIN is also indicated for prevention of DVT,
which may lead to PE, in patients undergoing hip replacement surgery, in
at- risk patients undergoing abdominal surgery and in at-risk acutely ill
patients whose mobility is severely restricted. FRAGMIN is also approved
for prophylaxis of ischemic complications resulting from unstable angina
and non- Q-wave myocardial infarction (heart attack), when used with

Important Safety Information


When neuraxial anesthesia (epidural/spinal anesthesia) or spinal
puncture is employed, patients anticoagulated or scheduled to be
anticoagulated with low molecular weight heparins or heparinoids for
prevention of thromboembolic complications are at risk of developing an
epidural or spinal hematoma which can result in long-term or permanent

The risk of these events is increased by the use of indwelling epidural
catheters for administration of analgesia or by the concomitant use of
drugs affecting hemostasis such as non steroidal anti-inflammatory drugs
(NSAIDs), platelet inhibitors, or other anticoagulants. The risk also
appears to be increased by traumatic or repeated epidural or spinal

Patients should be frequently monitored for signs and symptoms of
neurological impairment. If neurological compromise is noted, urgent
treatment is necessary.

The physician should consider the potential benefit versus risk before
neuraxial intervention in patients anticoagulated or to be anticoagulated
for thromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, Drug

FRAGMIN is contraindicated in patients with active major bleeding or
with known hypersensitivity to the drug, heparin, or pork products, or with
thrombocytopenia associated with a positive anti-platelet antibody test. It
should be used with extreme caution in patients with a history of heparin-
induced thrombocytopenia.

Patients undergoing regional anesthesia should not receive FRAGMIN for
unstable angina or non-Q-wave myocardial infarction, and patients with
cancer undergoing regional anesthesia should not receive FRAGMIN for
extended treatment of symptomatic VTE, due to an increased risk of bleeding
associated with the dosage of FRAGMIN recommended for these indications.

FRAGMIN cannot be used interchangeably (unit for unit) with
unfractionated heparin or other low-molecular-weight heparins.

FRAGMIN, like other anticoagulants, should be used with extreme caution
in patients who have an increased risk of hemorrhage; bleeding can occur at
any site during therapy. An unexpected drop in hematocrit or blood pressure
should lead to a search for a bleeding site.

The most commonly reported side effect is hematoma at the injection site.

Please see FRAGMIN for full prescribing information.

FRAGMIN is a registered trademark of Pfizer Health AB and is licensed
to Eisai Inc.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a
research-based human health care (hhc) company that discovers, develops and
markets products throughout the world. Eisai focuses its efforts in three
therapeutic areas: neurology, gastrointestinal disorders and
oncology/critical care. Established in 1995, Eisai Inc. began marketing its
first product in the United States in 1997 and has rapidly grown to become
an integrated pharmaceutical business with sales of approximately $2.2
billion in fiscal year 2005 (year ended March 31, 2006).

About Pfizer Inc

Founded in 1849, Pfizer is the world’s largest research-based
pharmaceutical company taking new approaches to better health. We discover
and develop innovative medicines to treat and help prevent disease for both
people and animals. Through consistent, high-quality manufacturing and
distribution operations, our medicines reach patients in 180 nations. We
also partner with healthcare providers, governments and local communities
around the world to expand access to our medicines and to provide better
quality healthcare and health system support. At Pfizer, our colleagues
work every day to help people stay happier and healthier longer and to
reduce the human and economic burden of disease worldwide.

Eisai Inc.; Pfizer Inc.


View drug information on Fragmin; Warfarin Sodium tablets.

Nightcap Before Bed May Affect Quality Of Sleep

While numerous studies have linked alcohol abuse to sleep disruption, especially in males, there has been little research on alcohol and its effects on sleep in females. Now, a new study shows that a moderate amount of alcohol, taken before bed, can impact the quality of sleep for young women.

“We found that a moderate dose of alcohol consumed by a young woman an hour before bed is associated with increased sleep intensity in the first couple hours of the sleep episode,” says author Mary A. Carskadon, PhD, with the Bradley Hospital Sleep and Chronobiology Laboratory and Brown Medical School.

This phenomenon was observed in well-slept women using an alcohol dose of 0.49 g/kg, equivalent to two to three standard drinks (in the form of vodka tonics), in the hour before bedtime, or 0.5 g/% below the legal limit for driving while intoxicated in many states.

Appearing in the June 2006 issue of the journal Alcoholism: Clinical and Experimental Research, this study looked at the sleep habits of young women (between ages 22 to 25) who drank alcohol before bed, over the course of three nights. Researchers monitored the women’s sleep and sleep electroencephalograms (EEGs), a graphic record of the electrical activity of the brain – a technique that can analyze the “microarchitecture” of sleep.

Researchers found few, but noteworthy differences between sleep and sleep EEG with alcohol versus placebo. When alcohol had been consumed, rapid eye movement (REM) sleep decreased, while stage 4 sleep (the deep sleep early in the night) was slightly increased. In addition, spectral analysis of the EEG showed signs of increased sleep intensity during non-REM (NREM) sleep after alcohol compared with placebo.

“Whether this sleep pattern is beneficial or harmful is unknown at this point. Although it may signal an initial consolidation of sleep, it might also be associated with difficulty waking in the event of an emergent problem, such as a fire or medical emergency,” says author Eliza Van Reen, a psychology graduate student at Brown University.

More work is needed to examine other alcohol doses, sex differences and vulnerability that may occur with a positive family history of alcoholism, the authors conclude.


Founded in 1931, Bradley Hospital (www.bradleyhospital) was the nation’s first psychiatric hospital operating exclusively for children. Today, it remains a premier medical institution devoted to the research and treatment of childhood psychiatric illnesses. Bradley Hospital, located in Providence, RI, is a teaching hospital for Brown Medical School and ranks in the top third of private hospitals receiving funding from the National Institutes of Health. Its research arm, the Bradley Hasbro Children’s Research Center (BHCRC), brings together leading researchers in such topics as: autism, colic, childhood sleep patterns, HIV prevention, infant development, obesity, eating disorders, depression, obsessive-compulsive disorder (OCD) and juvenile firesetting. Bradley Hospital is a member of the Lifespan health system.

Contact: Carol L. Vieira


Long-Term Care Insurance: Most Need It But Few Understand Why

When you think about your plans for
retirement, a nice place to live, traveling, playing golf and leaving an
inheritance for loved ones may all be part of your plan. Sounds lovely. But
what will happen to your plan if you become unable to care for yourself due
to an illness, accident or maybe just the effects of getting older? You’ll
need some type of long-term care, and that won’t come cheap.

“The reality is that 60 percent of Americans who reach age 65 will
someday need long-term care services and in many parts of this country,
these services can cost more than living in a five-star hotel,” said David
F. Woods, CLU, ChFC, president of the LIFE Foundation. “People need to
learn more about long-term care insurance and understand the chance they’re taking by not insuring themselves against the risk of one day needing assistance with the tasks of daily living. Delaying or avoiding the
decision to buy a long-term care insurance policy can mean the difference
between living your retirement years on your own terms or facing some very difficult financial realities.”

To encourage people to evaluate their long-term care insurance needs,
the nonprofit LIFE Foundation urges Americans to avoid five common excuses
people give for putting off a long-term care insurance purchase. As with
any insurance decision, LIFE advises that consumers meet with an agent to
learn more.

Excuse #1 – I can’t afford it

This is the most common reason given for not owning long-term care
insurance. Yet according to LIMRA International, a market research
organization, people who have never shopped for policies overestimate the
cost by as much as five to 10 times. Start evaluating coverage options when you first start thinking seriously about retirement, which experts say
should be in your 40s or early 50s at the latest. Long-term care insurance
can be quite affordable, especially if you buy at a relatively young age.
LTC Consultants estimate that $1,800 a year in premiums would buy a 40-year old couple three years of benefits at a daily payout of $140. If that same couple waited until they were 50 to buy, they would be paying $3,900 a year.

Excuse #2 – I won’t need it

According to the Centers for Medicare and Medicaid Services, about 10
million people of all ages already need help with the basic tasks of daily
living, and that number is projected to increase sharply as the population
continues to age. “Aging can be a steep emotional hurdle to face, however
people need to recognize that today’s long-term care environment isn’t the
same as what their grandparents experienced,” said LIFE Board Member Deb Newman, CLU, ChFC, LTCP, President of Newman Long Term Care.

“Most people will need long-term care and there are wonderful care options today, but only to those with the means to pay for them and that’s where long-term care insurance can be so essential.”

Excuse #3 – My health insurance, Medicare or Medicaid coverage will pay
for my care

Don’t count on it! Health insurance only pays for doctor and hospital
bills and maybe your prescription costs. Medicare only covers short-term
rehabilitative care that you receive after being hospitalized for at least
three days. Medicaid, on the other hand, does pay for long-term care
services but will only pay for care if you have very limited assets and
meet federal poverty guidelines. Moreover, having Medicaid pay for your
care also means you may not have much of a say in choosing the facility
that will provide your care.

Excuse #4 – My family will take care of me

Family members are often the first line of defense for loved ones who
need long-term care services, but this is often not a permanent or wise
solution. “Most people don’t want to depend on their loved ones to care for
them for the long-term,” said Newman. “Those in the ‘sandwich generation’
especially, who are currently taking care of both their aging parents and
their growing children, know the emotional and financial burden caring for
loved ones can bring. People should take steps now to make sure that when
the time comes, not all the responsibility of caring for them will fall on
the shoulders of their children or siblings.”

Excuse #5 – The buying process is too complicated

Long-term care policies do have a multitude of options and features,
which is why it is important to seek assistance from a qualified insurance
professional who specializes in these products. When you meet with an
advisor, pay particular attention to these five key product features:

— Daily benefit – This is how much the policy will guarantee to pay you
for covered services once your claim is approved. The amount of
coverage you will need is largely based on the average cost of care in
your area.

— Elimination period – This is the amount of time required before the
policy will begin making payments. Most policies have zero, sixty,
ninety, or even one-hundred and eighty day elimination periods. The
longer you’re willing to wait before benefits begin to be paid out, the
cheaper the premiums will be.

— Maximum benefit – This is the total amount the policy will pay once the elimination or waiting period has been satisfied. Many policies will
pay benefits for one, two or three years, and some will pay for a
lifetime. The length of your benefit your purchase usually comes down
to what you can afford. The longer the better.

— Types of facilities covered – Today, most policies will pay for care
rendered in a range of settings such as at home by a health aide, or in
an assisted living facility or nursing home. You’ll want to make sure
that all these choices will be available to you, especially the option
of receiving care at home, where most people prefer to live for as long
as they can.

— Inflation protection – Experts strongly recommend this because it
protects your policy from rising costs for care, due to inflation. Most
companies offer either 5% compound or 5% simple inflation. If you can afford it, the compound-interest option can make a big difference in
helping your benefit keep pace with the rapidly rising cost of care.

For additional information and helpful tips, visit the section of
LIFE’s website dedicated to long-term care insurance at

About LIFE

The Life and Health Insurance Foundation for Education (LIFE) was
founded in 1994 in response to the public’s growing need for information
and education on life, health, disability and long-term care insurance.
LIFE also seeks to remind people of the important role insurance
professionals perform in helping families, businesses and individuals find
the insurance products that best fit their needs. To learn more about these
topics, please visit life- line.

The Life Foundation