OTTAWA – Health Minister Ujjal Dosanjh today welcomed the new province-wide smoking bans in Manitoba and New Brunswick. Both provinces have banned smoking in all public places, including bars and restaurants. The legislation creates the strictest province-wide bans in the country.

“I would like to congratulate New Brunswick and Manitoba, who go smoke-free today, said Minister Dosanjh . “This is a significant milestone that highlights the impressive momentum that has been building across Canada towards establishing smoke-free work places. It is also a timely and eloquent response to the launch this week of mychoice a website funded by the Canadian Tobacco Manufacturers Council that seeks to turn back the clock on tobacco control.”

Heather Crowe, a longtime advocate of smoke-free workplaces, also welcomes the new legislation. Ms.Crowe never smoked a day in her life, but spent her career working as a waitress. She is now dying from lung cancer – a result of her exposure to second-hand smoke.

“I am delighted that smoking will now be banned in all public places in New Brunswick and Manitoba,” said Ms.Crowe, who has been featured in Health Canada’s advertisements promoting smoke-free workplaces. “I think this is a huge step forward for health and safety in the workplace.”

Every year, more than 45,000 Canadians die from disease or illness caused by using tobacco, and at least 1,000 of those are non-smokers. Cigarette smoke is the number one cause of visible indoor air pollution and second-hand smoke exposes people to cancer-causing pollutants. The financial costs associated with employee smoking are also significant. The most recent conservative estimates from 1995 show annual costs per smoking employee can be up to $2,565 per year due to increased absenteeism, decreased productivity, increased life insurance premiums, and smoking area costs. The most recent figures from 1991 estimate that smoking costs the Canadian health care system approximately $3.5 billion every year.

The primary mission of the Federal Tobacco Control Strategy (FTCS) is to reduce disease and death due to tobacco among Canadians. It recognizes that the key to success is comprehensive, integrated and sustained action, carried out in collaboration with all partners and directed at Canadians of all ages. Federal, provincial and territorial Ministers of Health are committed to working together to reduce tobacco consumption in Canada.

Health Canada has developed several resources to help workplaces go smoke-free, including Smoke-free Public Places: You Can Get There and Towards a Healthier Workplace: A Guidebook on Tobacco Control Policies. The Smoke-free Public Places toolkit offers hands-on, easy-to-use resources to help municipalities and communities through the various stages of planning, implementing and evaluating non-smoking by-laws and policies in public places. The Guidebook is designed to help employees and employers who are preparing to create or strengthen tobacco control policies in their workplace. These and other resources on second-hand smoke and help on how to quit smoking can be found at: www.GoSmokefree or by calling 1 800 O-Canada (1 800-622-6232).

Media Inquiries:
Margot Geduld/Carole Saindon
Health Canada
(613) 957-1588

Adиle Blanchard
Office of the Minister of Health
(613) 957-0200
Public Inquiries:
(613) 957-2991

A new article appearing in American Journal of Transplantation describes a revolutionary technique for more clearly identifying the possibility of organ rejection in kidney transplants. The technique, which uses a microarray or “Gene Chip,” a process of examining DNA sequences, defines how major causes of organ disease leading to rejection share similar disturbances in gene behavior. The study is the first to show how gene sets, as opposed to single genes, can be used for diagnosis of rejection in individual patients, and offers new insight into the mechanisms of these gene changes.

“The key problem in transplantation is to diagnose rejection. This has traditionally been done with the microscope by reading the appearance of the tissue. We are showing how this can be performed by reading the changes in expression of genes, and in particular, expression of sets of genes,” says Philip F. Halloran, M.D., lead author of the study and Editor-in-Chief of American Journal of Transplantation. “This is a more objective and accurate method of identifying the possibility of organ rejection.”

The authors established sets of genes – transcripts sets – based on disease pathogenesis. They found a threshold for expression below which the studied biopsies did not show evidence of rejection. The findings displayed a series of major biologic indicators that occur before and during organ rejection. The results showed that previous histologic criteria, particularly relating to the cut-off between borderline organ acceptance and rejection, are unreliable.

The gene behaviors identified showed strong correlations, indicating that disturbances leading to transplant rejection have stereotyped structures. Samples from the study that lacked these disturbances did not lead to organ rejection.

The features of this structure are also found in lower levels in many forms of organ disease and injury. “The system of reading biopsies that was developed in the study can be used with to help understand a variety of disease processes,” says Halloran.

Philip F. Halloran, M.D., Ph.D., OC, FRSC, is Director of the Alberta Transplant Applied Genomics Centre; a Professor in the Departments of Medicine and Medical Microbiology & Immunology at the University of Alberta; and Editor-in-Chief of American Journal of Transplantation. Dr. Halloran can be reached for questions at phil.halloranualberta.

The aim of the American Journal of Transplantation is the rapid publication of new high quality data in organ and tissue transplantation and the related sciences. The sciences include relevant aspects of cell biology, medicine, surgery, pediatrics, and infectious diseases. The journal includes thoracic transplantation (heart, lung), abdominal transplantation (kidney, liver, pancreas, islets), transplantation of tissues and related topics. For more information, please visit blackwellpublishing/ajt.

Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley’s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit blackwellpublishing or interscience.wiley.

Human activity is responsible for unprecedented contamination of water resources, leading to high levels of disease and infant mortality, with the poor paying the highest cost. This was the focus of the United Nations observance of World Water Day, which took the theme of “Clean Water for a Healthy World.” The observance – which was hosted by the Economic and Social Commission for Asia and the Pacific (ESCAP) and the UN Environment Programme (UNEP) – began with a message from UN Secretary-General Ban Ki-moon read by Shigeru Mochida, the Deputy Executive Secretary of ESCAP.

“Our growing population’s need for water for food, raw materials and energy is increasingly competing with nature’s own demands for water to sustain already imperiled ecosystems and the services on which we depend,” said Mr Ban. “Day after day, we pour millions of tons of untreated sewage and industrial and agricultural wastes into the world’s water systems.”

In Asia-Pacific, 620 million people live without adequate water and at least 1.8 billion people do without adequate sanitation. Every day, 2 million tons of sewage and other effluents drain into the world’s waters, aggravating water quality.

Nearly nine out of every 10 diarrhea incidents – which kill approximately 2.2 million people a year – are attributed to poor sanitation and dirty water. In South and South-East Asia, diarrhea is responsible for up to 8.5 per cent of all deaths, which is the highest in the world.

“The human cost is real: 25 per cent of infant mortality – children below 5 years – traces back to untreated sewage,” said Mr Mochida in his own remarks. “We all need water for survival, but more importantly, we need clean water for a healthy life.”

Young-Woo Park, the Regional Director of UNEP spoke about a recent meeting he attended where Ministers from small Pacific Islands spoke about receiving significant financial assistance without much actual change. He suggested it is time to stop asking the traditional questions and using traditional approaches, and look for new approaches to address the persisting environmental and development problems that are more in tune with the modern environment.

Thierry Facon, Senior Water Resources Expert at the UN Food and Agriculture Organization (FAO) said that agriculture contributes to more to water pollution then previously thought. Evidence from China presented by Mr. Facon indicated that efforts to reduce effluents from industry have been successful, but agricultural pesticides and fertilizers actually contribute much more contamination to river bodies.

In discussing community approaches, Somchai Chiracharoen, Mayor of the Muangklang Municipality, in the Rayong province of Thailand, presented the experience of his town, which cleaned up its river and kept it clean by involving people from the community to monitor pollution as part of a “river spy” programme.

Today’s event also included a team of students from the KIS International School, who presented the results of a bacteria count study of the Ampawa River in Thailand, which showed a high correlation between bacterial contamination and human settlements. The students’ message called for the “generation who contributed to the destruction of the environment” to see the “warning signs” and dare to change.

The keynote speech was delivered by Mr. Saksit Tridech, Permanent Secretary of the Ministry of Natural Resources and the Environment (MoNRE) of the Royal Thai Government, who spoke about the challenges of raising awareness on water quality in Thailand, but also of the great achievements made under the guidance and patronage of His Majesty the King of Thailand.

The celebration also involved an exhibition on water quality initiatives in Thailand and the region, highlighting that appropriate responses to water quality problems offer opportunities for development and for Green Growth.

Source
UN ESCAP

Elderly patients prescribed combination angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) had a higher risk of kidney failure and death, according to a study published in CMAJ (Canadian Medical Association Journal)

This study, by researchers from the University of Alberta and the University of Calgary, sought to determine the safety of combination therapy of ACE inhibitors and ARB in the clinical setting as some randomized trials indicate an increased risk of kidney failure. Randomized trials may over or underestimate the risk of adverse events possibly because of patient selection bias, higher drug doses and increased monitoring.

The researchers looked at 32 312 seniors in Alberta, Canada, aged 65 and older who were prescribed an ACE inhibitor and/or an ARB. They compared patients receiving both drugs together with patients who received only one of the drugs. They found a higher risk of adverse events such as high creatinine levels, end-stage renal disease and death in people taking combination therapy.

“We found that less than one-seventh of the elderly residents of Alberta who were given combination therapy in clinical practice had either of the conditions for which this therapy has been proven beneficial in randomized trials (i.e., proteinuria or symptomatic left ventricular systolic dysfunction despite treatment with and ACE inhibitor or an angiotensin-receptor blocker alone,” writes Dr. Finlay McAlister, University of Alberta, with coauthors.

As well, they observed that within three months, most patients stopped the combination therapy. The authors speculate this may have been due to low blood pressure.

“Our most striking findings were that combination therapy was commonly prescribed for patients who did not have the trial-proven indications and that it was frequently stopped after only a few months, even when hyperkalemia or renal dysfunction did not occur,” conclude the researchers.

Link to Article

Source
Canadian Medical Association Journal

Entomopathogenic fungi may be a safe and efficient means of controlling
Triatoma infestans, the bug that helps spread Chagas disease, according to
new
research conducted in Argentina. The study, published May 12 in the
open-access journal PLoS Neglected Tropical Diseases, shows the success of
the
fungi to kill bugs resistant to current control methods.

Chagas disease is the most relevant parasitic disease in Latin America,
being a major burden that affects mostly poor human populations living in
rural areas. The parasite Trypanosoma cruzi is mainly transmitted through
blood-feeding triatomine bugs; in the southern Cone of South America the
most prominent vector is Triatoma infestans. Current control strategies
based on residual chemical insecticide application are threatened by the
emergence of pyrethroid resistance.

The researchers, led by Patricia JuГЎrez, performed both laboratory and
field experiments showing that the entomopathogenic fungus Beauveria
bassiana
is virulent against bug populations from pyrethroid-resistant foci in the
Argentina/Bolivia border. An attraction-infection trap was developed and
tested during a 15-day period in field assays performed in two rural
villages, demonstrating that more than 50% of the bugs detected were
killed by
fungal infection. By existing vector population models, the bug population
reduction was estimated to reduce the risk of acquiring the parasite
infection.

This approach might also prove useful at different settings, e.g.
peridomiciliary environments where current tactics and procedures are
reported to
fail, and rural communities located in remote areas inaccessible to
sanitary control teams. The authors emphasize that these results might
help to
provide a safe and efficient alternative to overcome bug
pyrethroid-resilience in the short term, and might be useful to control
other Chagas disease
vectors as well.

Financial Disclosure:
Partial financial support came from the Pan American
Health Organization/World Health Organization/Special Program for Research
and Training in Tropical Disease (A20433), the Agencia Nacional de
Promocion Cientifica y Tecnologica, Argentina (PICT 01-14174), and the
Consejo
Nacional de Investigaciones Cientificas y Tecnicas (CONICET), Argentina,
to MPJ. The funders had no role in the study design, data collection and
analysis, decision to publish, or preparation of the manuscript.

Competing Interests:
NP, SJM, JRG, and MPJ have a patent pending on a
blood-sucking insect trap, and a method to detect and control those
insects.

Citation:
“Control of Pyrethroid-Resistant Chagas Disease Vectors with Entomopathogenic Fungi.”
Pedrini N, Mijailovsky SJ, Girotti JR, Stariolo R, Cardozo RM, et al. (2009)
PLoS Negl Trop Dis 3(5): e434.doi:10.1371/journal.pntd.0000434

Source
PLoS Neglected Tropical Diseases

UroToday – CLINICAL BRIEF: (Toronto, March 23, 2006, 6:30 PM EST) Society for Gynecologic Investigation (SGI), Scientific Poster 332, “Detection of Bladder Cancer in Women Using a Point-of-Care Assay.”

NMP22® BladderChek® Test Detected 100% of Dangerous Tumors in Women at Risk for Bladder Cancer

Clinical Results Presented at Society of Gynecologic Investigation Annual Meeting

Point-of-Care Test has utility as a Screening Tool for Women at Risk for Bladder Cancer

Overview:

Two leading clinical investigators, a UCLA gynecologist and a noted urologist and author, presented clinical results for Matritech’s NMP22® BladderChek® Test reporting it detected 100% of the aggressive tumors, one of which was muscle invasive, in women with symptoms or risk factors for bladder cancer. The NMP22 BladderChek Test was also positive for seven conditions that required biopsy for diagnosis. The data and the point-of-care NMP22 BladderChek Test were presented at the 53rd Annual Meeting of the Society for Gynecologic Investigation (SGI) in Toronto in a poster presentation, “Detection of Bladder Cancer in Women Using a Point-of-Care Assay.”

The clinicians noted that the NMP22 BladderChek Test has the potential to be an effective screening tool in identifying aggressive lesions early and improving prognosis in women at risk for bladder cancer. In other clinical studies it was shown to be an effective adjunctive tool in the diagnosis and monitoring of bladder cancer – improving cancer detection to 99%.

The data and the NMP22 BladderChek Test were introduced at the SGI meeting by Michael G. Ross, M.D., M.P.H., Professor of Ob/Gyn and Public Health, UCLA School of Medicine and Public Health and Chairman, Department of Ob/Gyn, Harbor-UCLA Medical Center, Los Angeles and Giora Katz, M.D., LakeShore Urology, and Holy Family Medical Center, Manitowoc, WI. Dr. Katz, a urologist, is a co-author of two studies published within the last year in the Journal of the American Medical Association (JAMA) reporting clinical results in the detection of bladder cancer using the NMP22 BladderChek Test.

Commentary by the authors:

“This is good news for women and their doctors – we can detect bladder cancer earlier. Although bladder cancer hasn’t been a major focus of gynecological medicine, it is a significant issue for women because the prevalence of bladder cancer is similar to ovarian and cervical cancers,” said Dr. Ross. “Women tend to be diagnosed later than men. These data support our message to gynecological specialists: Bladder cancer is very treatable if detected early.”

Dr. Ross emphasized, “As gynecologists it’s important to recognize our role in the early detection of bladder cancer. We now have the means to screen women for bladder cancer using a nuclear matrix protein assay, especially when hematuria [blood in the urine] is a presenting symptom. If the NMP22 test is positive, women at risk should be further evaluated for bladder cancer by an uro-gynecologist or urologist.”

Hematuria is the most frequent symptom of bladder cancer. “Of all the bladder cancer symptoms, hematuria or blood in the urine is very significant,” said Dr. Ross. “However, there are many reasons for hematuria, more for women than for men.”

“Often hematuria is a misleading symptom, one which women tend to ignore,” adds Dr. Katz. “This may explain why a greater percentage of women are diagnosed at a later stage of the disease. Hematuria can be intermittent and its degree does not correlate with the severity of the cancer. Unfortunately, that may contribute to the higher mortality rates for women.”

In this investigation, all the women diagnosed with bladder malignancy had hematuria. The American Urological Association (AUA) Best Practice Policy recommends that high risk patients with hematuria undergo an evaluation for bladder cancer even after a single episode.

Dr. Katz, a principal investigator in two large multi-site clinical trials evaluating hematuria and bladder cancer detection said, “Women with a history of smoking, environmental or occupational exposure to chemicals, or who present with hematuria or dysuria [painful or difficult urination] and are negative for urinary tract infection should be considered for evaluation of bladder cancer.” He added, “We need to educate both our patients and their physicians about this cancer and use the best tools we have to diagnose them early. The NMP22 BladderChek Test helps us focus our search earlier, expediting our diagnosis and adding a measure of confidence for the physician in determining the cause of the hematuria. I use it in my practice because it is an easy to use noninvasive urine test that provides a result while my patient is in the office. It’s proven to increase the detection of cancer, and it’s half the cost of laboratory tests.”

Dr. Ross also noted that many women who are otherwise conscientious about their health are unaware about the prevalence and impact bladder cancer can have on their lives. According to the National Institutes of Health (NIH) SEER data, bladder cancer is almost as prevalent in women as ovarian and cervical cancers. Bladder cancer also has the highest recurrence rate of any cancer.

This year’s SGI annual meeting focused on gender and ethnic disparities. The disparity between women and men in both the diagnosis of bladder cancer and five year survival rates is compelling. Bladder cancer occurs more frequently in men than women, but women have a disproportionately higher death rate. There is a higher percentage of men who survive for ten years after diagnosis than women who survive for five. However, the five year survival rate for bladder cancer is 92% in women if tumors are detected while they are still confined in the bladder lining, but drops to 43% or less once they become invasive. Also, there is growing evidence that when smoking factors are comparable, the risk of bladder cancer in women may be higher than that in men.

Cigarette smoking is the most common risk factor and doubles the risk of bladder cancer. In fact, smoking accounts for 30% of bladder cancer deaths in women. Occupations that involve organic chemicals and dyes, such as beautician, dry cleaner, painter, paper production worker, rope and twine industry worker have been reported to increase risks. Other industrial exposures implicated as risk factors for developing bladder cancer include combustion gases and soot from coal, chlorinated aliphatic hydrocarbons, and chlorination by-products in heated water. The other associated occupations to these risk factors include firefighter, truck driver, plumber, leather and apparel worker, autoworker, and rubber and metal workers.

SGI Poster 332 (jpeg)
www.urotoday/images/nmp22_bladdercheck.jpg

About the NMP22® BladderChek® Test

The NMP22® BladderChek® Test was developed and commercialized by Matritech, a leading developer of protein-based diagnostic products for the early detection of cancer. The NMP22® BladderChek® Test detects elevated levels of the NMP22 protein marker in a single urine sample. Most healthy individuals have very small amounts of the NMP22 protein marker in their urine, but bladder cancer patients commonly have elevated NMP22 protein marker levels, even at early stages of the disease. A study published in the Journal of the American Medical Association (JAMA) in January, 2006 demonstrated that the NMP22 BladderChek Test used in combination with cystoscopy (a visual examination of the bladder), detected 99% of bladder malignancies. The NMP22 BladderChek Test also detected cancers that were missed during an initial cystoscopic examination, most of which were high grade.

The NMP22® BladderChek® Test, a painless and noninvasive assay, is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The BladderChek® Test, which is reimbursed by Medicare and other medical insurers, is more cost effective than cell-based laboratory cytology tests. It is approved for use in a physician’s office with results available in 30 minutes – during the patient visit, allowing a rapid, accurate and cost-effective way to aid in the detection of bladder cancer.

About Matritech

Matritech is using its patented proteomics technology to develop diagnostics for the detection of a variety of cancers. The Company’s first two products, the NMP22® Test Kit and NMP22® BladderChek® Test, have been FDA approved for the monitoring and diagnosis of bladder cancer. The NMP22 BladderChek Test is based on Matritech’s proprietary nuclear matrix protein (NMP) technology, which correlates levels of NMPs in body fluids to the presence of cancer. Beginning with a patent portfolio licensed exclusively from the Massachusetts Institute of Technology (MIT), Matritech’s patent portfolio has grown to more than 15 other U.S. patents. In addition to the NMP22 protein marker utilized in the NMP22 Test Kit and NMP22 BladderChek Test, the Company has discovered other proteins associated with cervical, breast, prostate, and colon cancer. The Company’s goal is to utilize these protein markers to develop, through its own research staff and through strategic alliances, clinical applications to detect cancer. More information about Matritech is available at matritech.

Statement under the Private Securities Litigation Reform Act

Any forward-looking statements relate to the Company’s current expectations of the Company’s product sales and technology. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in the Company’s business, including without limitation risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for the Company’s products, the impact of competitive products and pricing, and technical challenges in completing product and technology development. Please refer to the risk factors detailed in the Company’s periodic reports and registration statements as filed with the Securities and Exchange Commission. These forward-looking statements are neither promises nor guarantees. There can be no assurance that the Company’s expectations for its products or future financial performance will be achieved. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Matritech undertakes no responsibility to revise or update any such forward-looking information.

Authors:

Giora Katz, M.D., Urologist, LakeShore Urology, Manitowoc, WI. Co-author of two studies published within the last year in the Journal of the American Medical Association (JAMA) reporting clinical results in the detection of bladder cancer using the NMP22® BladderChek® Test.

Michael G. Ross, M.D., M.P.H., Professor of Ob/Gyn and Public Health, UCLA School of Medicine and Public Health and Chairman, Department of Ob/Gyn, Harbor-UCLA Medical Center, Los Angeles

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Reliant Pharmaceuticals today announced a submission to the U.S. Food and Drug Administration (FDA) to seek approval for the expanded use of Omacor (omega-3-acid ethyl esters) as an adjunct to diet and statin therapy in adults whose triglyceride levels are high (200-499 mg/dL).В  As part of this filing, Reliant submitted new data from the recently completed Combination of Omacor and Simvastatin (COMBOS) trial that evaluated the efficacy and safety of Omacor as an adjunct to diet and simvastatin therapy for the treatment of high triglycerides. В COMBOS is a randomized, double-blind, placebo-controlled, parallel-group study including 254 patients.

“Currently, Omacor may help up to 5 million Americans whose triglyceride levels are very high,” said Steven Ketchum, Ph.D., Senior Vice President, Research and Development, Reliant Pharmaceuticals.В  “There are an estimated 27 million Americans who struggle to control high triglycerides.В  By seeking this expanded indication, Omacor may serve as a safe, new treatment option for adults whose triglyceride levels remain high in spite of statin therapy.”

Omacor is the first and only FDA-approved, prescription omega-3 fatty acid product, and has been proven safe and effective in clinical studies as an adjunct to diet to reduce very high triglycerides (≥500 mg/dL) in adult patients.  Very high triglycerides (≥500 mg/dL) impact 4-5 million people in the United States.  Omacor contains the key omega-3 components, eicosapentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), to reduce very high triglycerides, and is naturally derived through a unique, patented process that consistently creates a highly concentrated and purified prescription medicine.

When Omacor was granted FDA approval in 2004, the FDA issued an approvable letter for the use of Omacor as an adjunct to diet and statin therapy to reduce high triglyceride levels (200-499 mg/dL) in adult patients.В  Submission of this response is intended to demonstrate the safety and efficacy of the expanded use of Omacor before FDA approval is granted.

В 
About High Triglycerides

Like the other types of cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the body. Triglycerides are derived from either fats ingested from food or other energy sources like carbohydrates in the body.В  After a meal, the calories that are not used immediately by tissues are then converted into triglycerides and distributed among fat cells to be stored.В  Hormones found in the body then regulate the release of triglycerides from fat tissue so they may be used for energy between meals. В According to the American Heart Association (AHA), a normal level of triglycerides is below 150 mg/dL.В  Like cholesterol, triglyceride levels can be detected by a blood test.В  A high triglyceride level causes a condition known as hypertriglyceridemia, which is linked to the occurrence of heart disease in some people.

В 
Important Omacor Safety Information

Omacor is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in adults. Before taking Omacor, your healthcare provider should help you try to control your very high triglyceride levels by: losing weight if you are overweight, increasing physical exercise, lowering alcohol use, treating diseases such as diabetes and low thyroid hormone levels (hypothyroidism), and adjusting other medications that may raise triglyceride levels such as certain blood pressure medications and estrogens.

В 
Omacor should be used with caution in people allergic to fish.В  Treatment to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals.В  The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.

В 
Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding.В  Tell your healthcare provider if you take blood thinners.В  If you take both Omacor and a blood thinner, your healthcare provider should monitor your clinical response.

В 
The most common side effects observed in Omacor clinical trials were belching, infection, flu symptoms, upset stomach, rash and change in your sense of taste.В 

В 
For more detailed information about Omacor, ask your healthcare provider or go to omacorrx.

В 
About Reliant Pharmaceuticals

Reliant Pharmaceuticals is a pharmaceutical company with integrated sales, marketing and development expertise that markets a portfolio of branded cardiovascular pharmaceutical products.В  Reliant focuses on marketing promotionally sensitive pharmaceutical products to the high prescribing primary care, cardiovascular and specialist physician markets in the United States.В  Reliant also acquires rights to and develops product candidates in mid- to late-stage clinical development.В  Reliant’s sales force infrastructure is comprised of approximately 825 sales professionals nationwide.

В 
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995.

В  To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission.

Blacks and poor individuals are more likely to be donors while whites and wealthier individuals are more likely to be
recipients of many types of transplant organs, according to a new study in the November 2004 issue of the American Journal of
Medicine. The study was conducted by Ashwini Sehgal, M.D., director of the Center for Reducing Health Disparities at Case
Western Reserve University and a nephrologist at MetroHealth Medical Center in Cleveland, Ohio.

The investigation examined over 100,000 transplants performed in the United States from 1996 to 2001 and found that blacks
were more likely to be donors while whites were more likely to be recipients for 6 of 8 types of deceased donor transplants
(heart-lung, intestine, kidney-pancreas, liver, lung, and pancreas). Poor individuals were more likely to be donors while
wealthier individuals were more likely to be recipients for 7 of 8 types of deceased donor transplants.

Transplantation is the best treatment for many types of permanent organ failure. Organs for transplantation may come from
deceased donors (brain dead individuals whose families have consented to donate) or from living donors (usually close
relatives with compatible blood and tissue types). A scarcity of both deceased and living donors means that most patients
with organ failure never receive transplants. While payment to donors of any kind is currently illegal in the United States,
periodic efforts are made to allow financial incentives as a way to encourage donation.

This study raises concerns about efforts to offer financial incentives since minorities and the poor may be
disproportionately affected by such incentives.

“There are already widespread disparities in who donates and who benefits from organ transplantation. Adding financial
incentives to the system might make these race and income disparities even worse,” said Sehgal.

Kidney transplants were an exception to the general pattern. Blacks and poor people were more likely to receive than donate
kidneys. This is probably due to two factors. First, Medicare pays for virtually all treatment for permanent kidney failure
in the United States, regardless of patient age. This means blacks and poor individuals have access to medical care,
including kidney transplantation. Second, blacks and poor people have much higher rates of kidney failure than whites and
wealthier individuals.

The main finding for living donor transplants involved spousal transplants. Wives were twice as likely to donate to husbands
than husbands to wives.

Sehgal emphasized the need to understand the causes of disparities in donating and receiving transplant organs. Some
disparities may be unavoidable or even desirable. For example, ensuring a good tissue type match improves survival of
transplanted organs but may make it harder for blacks to receive organs. Disparities that are both avoidable and undesirable
are more concerning. For example, lack of health insurance may act as a barrier to transplantation among blacks and the poor.

Contact: George Stamatis
George.Stamatiscase.edu
216-368-3635
Case Western Reserve University

By 2011 it’s projected that Australia will spend more than $600 million annually on health services related to falls in adults aged 65 and older. Identification of those at risk of falling could be improved by the use of simple cognitive tests, a pioneering study proposes.

The results of the first long-term study comparing mental ability and fall rates among elderly Australians have been published by researchers from The Australian National University and Flinders University in the Journal of the American Geriatrics Society.

“The proportion of people aged over 65 in Australia is growing rapidly – and falls are one of the biggest causes of health problems for older people,” project leader Dr Kaarin Anstey from the Centre for Mental Health Research at ANU said.

“Using data collected as part of the Australian Longitudinal Study of Aging, we found that people with lower or declining cognitive ability are at greater risk of falling. This result was found among those who did not have dementia or cognitive impairment.

The study followed more than 500 people aged 70 over an eight-year period. Participants were tested at regular intervals for a range of cognitive abilities, motor skills, and health factors. They were then asked about the number of falls they experienced per year. Those people who showed lower or declining mental abilities were found to be at much greater risk of falling

“Previous studies have been much shorter, and tended to focus on the ‘obvious’ things that would increase the risk of falling, such as visual or motor impairment, psychotropic medication and dementia,” Dr Anstey said. “We adjusted for all these contributors, and still found that cognitive ability was a reliable indicator of fall risk.”

The study found that women were more likely to experience falls at all stages, and that multiple fallers were more likely be older and female. Dr Anstey said such findings would support a change in focus for health workers. “By adding to the existing tests for fall risk with brief measures of verbal reasoning, processing speed or memory, it may be possible to improve early interventions for falling and cut the rate of falls among older Australians,” she said.

###

The research team included Professor Mary Luszcz from the University of Flinders and Chwee von Sanden from ANU. The study received funding from the South Australian Health Commission, the Australian Rotary Health Research Fund and the US National Institutes of Health. Dr Anstey is funded by a National Health and Medical Research Council Fellowship.

Contact: Simon Couper

Research Australia

More than one million Americans currently participate in the Alcoholics Anonymous (AA) program. While AA participants are reportedly notorious for their coffee drinking and cigarette smoking, very little research has quantified their consumption of these two products. Recent findings confirm that coffee and cigarette use among this population is greater than among the general U.S. population: most AA members drink coffee and more than half smoke.

Results will be published in the October issue of Alcoholism: Clinical & Experimental Research and are currently available at Early View.

“Drinking coffee and smoking cigarettes are part of the culture of AA, but we knew little about the degree to which this occurred, how much more prevalent these behaviors were compared to the general American population, or why AA participants actually drank coffee or smoked cigarettes,” said Peter R. Martin, professor of psychiatry and pharmacology, director of the Vanderbilt Addiction Center at the Vanderbilt University School of Medicine, and corresponding author for the study.

Martin added that many questions remain about the effects of coffee and cigarettes on recovering alcoholics. “What do cigarettes or coffee do for them; how do they believe that they are affected by smoking and drinking coffee?,” he asked. “Is this behavior simply a way to bond or connect in AA meetings, analogous to the peace pipe among North American Indians, or do constituents of these natural compounds result in pharmacological actions that affect the brain? Perhaps most interesting, how do these consummatory behaviors affect the brain and what is their role in recovery?”

While the most common cause of death in long-term recovering alcoholics is related to the health consequences of cigarette smoking, Martin noted, recent epidemiological studies have shown that coffee consumption is not harmful to health and may, in fact, reduce the risk of death from suicide, certain cancers, and other diseases.

While that may be true, noted Robert Swift, professor of psychiatry and human behavior at Brown University Medical School, little is known about coffee’s role vis-Г -vis abstinence, whether drinking coffee makes it easier or harder to stay sober. “It’s possible that coffee is even a gateway drug, with coffee drinking beginning at about the time persons begin using alcohol. In addition, a potential negative interaction is coffee’s known negative effects on sleep. Many alcoholics in long-term recovery frequently have trouble with sleep, and coffee consumption could make sleep problems worse.”

A strength of this study, Swift added, is that relatively little is known about AA, why some persons are helped by it while others are not. “The authors have been successful in gaining the confidence of AA groups and incorporating them into a research study,” he said.

Martin and his colleagues asked participants (n=289) in all open AA meetings during the summer of 2007 in Nashville, TN to self-report a variety of information: a “timeline followback” for coffee, cigarette and alcohol consumption, the AA Affiliation Scale, coffee consumption and effects questions, the Fagerstrom Test for Nicotine Dependence, and the Smoking Effects Questionnaire.

“The most important finding was that not all recovering alcoholics smoke cigarettes while almost all drink coffee,” said Martin.

More specifically, most individuals (88.5%) consumed coffee and approximately 33 percent drank more than four cups per day. The most common self-reported reasons were because of coffee’s stimulatory effects: feeling better, better concentration, greater alertness. More than half of the respondents (56.9%) smoked cigarettes; of those, 78.7 percent smoked at least half a pack per day, and more than 60 percent were considered highly or very highly dependent. The most common self-reported reasons were because of smoking’s reduction of “negative affect,” which refers to depression, anxiety and irritability. “Many of these negative affective states are described by patients as contributors or triggers to relapse after periods of sobriety,” said Martin.

“I think that it is important for alcohol researchers and clinicians to know that alcoholics, even those who do not use other illicit drugs, are not just addicted to alcohol, but use other psychotropic drugs like caffeine and nicotine,” said Swift. “I found it interesting that coffee contains a lot of psychoactive substances, in addition to caffeine. A second important aspect is the finding that rates of smoking are much higher in alcoholics in recovery than in the general population. Smoking kills and is at least as harmful for alcoholics as is alcohol. Yet, AA tolerates or otherwise does not address smoking in its members.”

“Yet, if coffee is beneficial and cigarettes are harmful to health, AA members seem to be going in the right direction by reducing smoking and perhaps increasing their coffee drinking,” observed Martin. “We are now working on more detailed analyses of results to examine whether these changes in coffee and cigarette use are predictive of recovery from alcoholism per se.”

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Alcoholism: Clinical & Experimental Research (ACER) is the official journal of the Research Society on Alcoholism and the International Society for Biomedical Research on Alcoholism. Co-authors of the ACER paper, “Coffee and Cigarette Consumption and Perceived Effects in Recovering Alcoholics Participating in Alcoholics Anonymous in Nashville, TN,” were: Michael S. Reich and A.J. Reid Finlayson in the Vanderbilt Addiction Center in the Department of Psychiatry at Vanderbilt University School of Medicine; Mary S. Dietrich in the Department of Biostatistics at the Vanderbilt University School of Medicine; and Edward F. Fischer in the Department of Anthropology at Vanderbilt University. The study was funded by the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse.

Source: Peter R. Martin, M.D.

Vanderbilt University School of Medicine

Alcoholism: Clinical & Experimental Research