If you plan to “thrive” when you are 65, you need to invest in your health decades earlier. A new study in the October issue of The Journal of Gerontology: Medical Sciences (Volume 63A, Number 10) finds that fewer than 10 percent of people aged 65-85 maintain exceptional emotional and physical health throughout their golden years. These so-called “thrivers” share specific behavioral and lifestyle characteristics that may hold the key to healthy aging, according to the study’s authors.

“Important predictors of thriving were the absence of chronic illness, income over $30,000, having never smoked, and drinking alcohol in moderation,” said lead author Mark Kaplan, DrPH, of Portland State University. “We also found that people who had a positive outlook and lower stress levels were more likely to thrive in old age.”

“Many of these factors can be modified when you are young or middle-aged,” said co-author David Feeny, PhD, of the Kaiser Permanente Center for Health Research. “While these findings may seem like common sense, now we have evidence about which factors contribute to exceptional health during retirement years.”

This is the first research to evaluate which factors help older people maintain exceptional health over a long period of time. Most previous investigations have focused on factors that contribute to poor health, and they have made those determinations based on one-time surveys.

This study included 2,432 Canadian residents, aged 65-85, who filled out an extensive health survey every other year from 1994-2004. One measure, called the Health Utilities Index Mark 3, asked people to rate their abilities in eight categories, including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Thrivers were those who rated themselves as having no or only mild disability in all eight categories on at least five of the six surveys.

If respondents reported moderate or severe disability on any of the six surveys, they were classified as non-thrivers. Just over half (or 50.8 percent) of the respondents started out as thrivers, but by the end of the ten years, only 8 percent of the respondents were considered thrivers. By the end of the study period, just under half (47 percent) of the respondents were classified as non-thrivers. The rest (36 percent) had either died or were institutionalized (9 percent).

“Even though the study was conducted in Canada, the findings are certainly applicable to the United States and other industrialized nations,” said co-author Bentson McFarland, MD, PhD, of the Oregon Health & Science University. “Our population here in the United States is similar demographically to Canada’s, and both health care systems rely on the same underlying technologies,” says McFarland.

The study was funded by a grant from the National Institute on Aging.

The Journal of Gerontology: Social Sciences is a refereed publication of The Gerontological Society of America, the nation’s oldest and largest interdisciplinary organization devoted to research, education, and practice in the field of aging. The principal mission of the Society – and its 5,000+ members – is to advance the study of aging and disseminate information among scientists, decision makers, and the general public. GSA’s structure also includes a policy institute, the National Academy on an Aging Society, and an educational branch, the Association of Gerontology in Higher Education.

The Gerontological Society of America

U.S. Department of Health and Human Services Secretary Kathleen Sebelius released an examination of the federal government’s system to produce medications, vaccines, equipment and supplies needed for a health emergency, known as medical countermeasures. The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs reviews the process and makes recommendations for a better approach.

“Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it’s a threat we know about today or a new one,” Secretary Sebelius said. “By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats.”

Secretary Sebelius requested the comprehensive review when the department encountered challenges with the 2009 H1N1 pandemic flu vaccine, highlighting the need for a modernized countermeasure production process. The review covered the steps involved in the research, development, and FDA approval of medications, vaccines, and medical equipment and supplies for a health emergency.

The review identified a need to upgrade science and regulatory capacity at the FDA. As a result, HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.

The review also found that U.S. must more quickly develop manufacturing processes that can be used for multiple medications or vaccines rather than processes that can be used to produce only one type of countermeasure. As a result of this finding, in the coming weeks HHS expects to release a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will focus on new manufacturing platforms that can produce a variety of countermeasures. The equipment and methods could provide a way to meet a surge in demand using facilities in the U.S. rather than relying on foreign manufacturing.

The review found that some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing. Therefore, the Centers of Innovation for Advanced Development and Manufacturing will also serve as resources for young companies, helping them bring products to market and helping the U.S. government increase the number of new countermeasures available in an emergency.

The review made clear that the federal government must do a better job nurturing discoveries in their earliest stages to push them to greater maturity. Therefore, HHS will be creating new teams at the National Institutes of Health to identify promising research and facilitate its translation into vaccines, drugs, and treatments that keep Americans safe.

The review placed a special focus on the federal government’s flu response, identifying a need to upgrade flu vaccine manufacturing – from modernizing ways to test a vaccine’s strength, known as potency, to new methods to show that the vaccine is safe, as well as ways to produce the early “seed virus” for vaccines faster. Taken together, this will shave weeks of time off vaccine manufacturing. HHS will make investments in these areas as a result of the review.

The review also found that private companies have difficulty attracting investors in countermeasures where there is little or no market for these products outside of that currently needed for government stockpiles. As a result of this finding, HHS will explore ways to help small companies attract investors to develop promising countermeasures that have multi-use potential.

The HHS Assistant Secretary for Preparedness and Response led the review. All federal agencies working with medical countermeasures participated, including the Department of Homeland Security, Department of Defense, and HHS divisions of ASPR and ASPR’s Biomedical Advanced Research and Development Authority, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration. The review also incorporated input from state and local health departments, two federal advisory committees of outside experts, industry groups, venture capital experts, and the Institute of Medicine.

Source:

HHS

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) today announced that new clinical trial data concerning the safety and efficacy of the Company’s NX-1207 for benign prostatic hyperplasia (BPH) will be presented at the Annual Meeting of the Western Section of the American Urological Association Meeting being held in Monterey, CA from October 26 to 30, 2008. The podium paper is authored by leading independent clinical research investigators participating in the U.S. clinical trials of NX-1207.

NX-1207 is a novel drug developed by Nymox for the treatment of BPH. The drug has been in a number of blinded controlled multi-center U.S. clinical trials where it has been found to produce improvements that are about double that reported for currently approved BPH drugs. NX-1207 is administered by a urologist in an office procedure that takes only a few minutes and involves little or no pain or discomfort. Patients notice improvement as early as a week or two after treatment. Follow-up studies have shown that many men showed continued benefit from a single NX-1207 treatment for 2 years or more. NX-1207 treatment does not require the patient to take pills daily for the rest of his life, like currently approved BPH medications.

Blinded clinical trials to date have shown that men treated with NX-1207 reported statistically significant improvement in BPH symptoms 3 months after a single NX-1207 treatment with no reported serious drug-related side effects, including no significant sexual side effects. In two multi-center Phase 2 U.S. prospective randomized blinded clinical trials, the aggregated mean improvement in the Primary Endpoint of BPH Symptom Score for 2.5 mg NX-1207 was 10.3 points or a 44% improvement in Symptom Score.

Results of 6 follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment for up to 4ВЅ years from the date of treatment. The Company recently announced statistically significant improvement compared to placebo in a 22 to 33 month follow-up study of 93 patients treated with NX-1207 at 17 U.S. clinical trial sites. Results in that study showed that patients at follow-up without any other treatment for BPH had a mean of 11.3 points BPH Symptom Score reduction, which represents a 47% improvement in symptoms from before treatment.

BPH treatment represents a growing market with more than 100 million men worldwide being estimated to suffer from BPH symptoms. The disorder is a common affliction of older men, affecting approximately half of men over age 50 and close to 90% of men by age 80, and is associated with growth in prostate size as men age. BPH causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems, and can cause acute urinary retention requiring immediate medical attention.

This press release contains certain “forward-looking statements” as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox’s filings with the United States Securities and Exchange Commission and other regulatory authorities.

nymox

Telmisartan, a drug widely used to help control blood pressure, may have uniquely potent activity in preventing stroke, according to a new study conducted in an animal model.

Whether they used the drug alone or in combination with a different type of antihypertensive medication, ramipril, Weill Cornell Medical College researchers found that rats fed a high-salt, stroke-inducing diet were completely protected from the brain attacks while on telmisartan.

“No other study has ever shown complete protection against stroke in this rat model using normal human drug doses” notes study senior author Dr. Daniel F. Catanzaro, professor of physiology and biophysics and professor of physiology in cardiothoracic surgery at Weill Cornell Medical College.

The study, which was funded by telmisartan’s German maker, Boehringer Ingelheim Pharma GmbH & Co., is published online in the Journal of the American Society of Hypertension.

Telmisartan (brand name Micardis) is one of a class of widely used antihypertensive drugs known as angiotensin receptor blockers (ARBs). “These drugs primarily act on the vasculature to relax the small blood vessels,” Dr. Catanzaro explains.

Telmisartan stands out from other ARBs in that its molecular structure allows it to more easily pass through the blood-brain barrier and enter the brain — something many drugs cannot do.

The new animal study was not constructed to specifically look at telmisartan’s effect on stroke. “Because blood pressure is closely related to stroke risk, we really just wanted to look and see if combinations of antihypertensive drugs were better at lowering blood pressure and stroke compared to the use of single agents,” Dr. Catanzaro explains.

In this case, his team tested two drugs — telmisartan and an ACE inhibitor, ramipril (Altace) — in a rat model long favored by stroke researchers. In this approach, rats are fed what’s known as a “stroke-prone diet,” meaning they get lots of salt in both their food and water.

“This rat model has been great at showing us the neuroprotective properties of different drugs in the past, and the results usually correlate with results in humans,” Dr. Catanzaro says.

In the study, 25 rats were fed the stroke-prone diet for 8 weeks and received either no medication, telmisartan alone, ramipril alone, or the two drugs together at either full- or half-doses.

“A main finding was that combination therapy did reduce blood pressure the best of any treatment, and it also was best at cutting damage to the rats’ hearts and kidneys,” Dr. Catanzaro says. “But what was really surprising to us was that any regimen involving telmisartan at doses that would normally be given to humans completely prevented stroke in this model. Most studies with other drugs have used much higher doses and have found only partial protection.”

Specifically, 83 percent of rats given no medication showed signs of stroke, as did 56 percent of rats given ramipril alone. However, no strokes were noted in the telmisartan-only or the telmisartan/ramipril combo groups.

Telmisartan’s ability to easily pass through the blood-brain barrier (something ramipril cannot do) is likely behind the neuroprotective effect noted in the study, the researchers say.

“Going forward, that’s something that we would really like to test out in head-to-head trials pitting telmisartan against other ARBs, for example,” Dr. Catanzaro said. “At the same time, we’d like to examine whether telmisartan is actually getting into the brain, or if more peripheral effects — a lowering of blood pressure, for instance — are behind the reduction in stroke.”

In the meantime, Boehringer Ingelheim is nearing the end of a major clinical trial looking at the effectiveness of combining telmisartan with ramipril to lower patients’ blood pressures and reduce their odds for heart attack and stroke. Dr. Catanzaro’s team is not involved in that study.

Co-authors on this study include lead researcher Dr. Ying Zhou, as well as Dr. Fangmin Yu and Dr. Ada R. Ene — all of Weill Cornell Medical College in New York City.

Weill Cornell Medical College

Weill Cornell Medical College — Cornell University’s Medical School located in New York City — is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Weill Cornell, which is a principal academic affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum that integrates the teaching of basic and clinical sciences, problem-based learning, office-based preceptorships, and primary care and doctoring courses. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research in such areas as stem cells, genetics and gene therapy, geriatrics, neuroscience, structural biology, cardiovascular medicine, infectious disease, obesity, cancer, psychiatry and public health — and continue to delve ever deeper into the molecular basis of disease in an effort to unlock the mysteries behind the human body and the malfunctions that result in serious medical disorders.

The Medical College — in its commitment to global health and education — has a strong presence in such places as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. With the historic Weill Cornell Medical College in Qatar, the Medical School is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient.

Weill Cornell Medical College

View drug information on Micardis HCT.

The Rockefeller Foundation has awarded the Cummings School of Veterinary Medicine at Tufts University a grant to assess veterinary health services in Indonesia and consider how advanced training of Indonesian veterinarians can enhance Indonesia’s capacity to prevent and control infectious diseases shared by animals and people. The $200,000 grant was made through the Foundation’s Pandemics Initiative, which aims to promote resilience of poor and vulnerable people to emerging pandemic threats to health and livelihoods by supporting integration of fragmented systems of surveillance and response.

“Animals are the likely source of 75% of the world’s emerging infections. In the event of a zoonotic disease outbreak, the world’s poorest people, who largely depend on animals for their livelihoods, are hit the hardest with threats of disease, malnutrition and economic destitution. At the same time, we see a divide between the fields of veterinary health and human health leading to poor communication and inefficient use of resources to detect and respond to outbreaks,” said Tara Acharya, PhD, MPH, Associate Director at the Rockefeller Foundation “We are pleased to support the efforts of Tufts University to improve community-level surveillance, responses and management of animal diseases that threaten the health of animal and human populations and the livelihoods of Indonesian families”

The award will build upon a nationwide community-based training program for prevention and control of highly pathogenic Avian Influenza (HPAI) in Indonesia led by the Cummings School. With the support of the Rockefeller Foundation, the Cummings School will test the effectiveness of Indonesia’s veterinary training and education system using HPAI and apply its findings to other diseases that may be transmitted from animals to people.

The Cummings School’s program in Indonesia, known as the Participatory Disease Surveillance and Response (PDS/R) project, focuses on early warning and early reaction to avian flu. Eight Tufts veterinarians and a senior administrator have worked with the Indonesian Government, non-government organizations, and private citizens to establish a nationwide, community-based network of 1,200 teams that monitor and respond to outbreaks of avian influenza. The Cummings team also assists the Ministry of Agriculture in training local government animal health officials in the basics of participatory epidemiology, poultry health, community mobilization, and disease control methods.

“The PDS/R Project in Indonesia has taught us many things about how to mobilize communities against an infectious disease outbreak, and these lessons can be applied to controlling zoonotic diseases around the world,” said Deborah Kochevar, DVM, PhD, dean of the Cummings School of Veterinary Medicine at Tufts University. “Thanks to the support from the Rockefeller Foundation, we hope to expand this important public health project.”

The project illustrates the essential role of veterinarians in public health, a concept embraced by the “One Health” Initiative. This initiative unites physicians, veterinarians, public health professionals and the private sector in efforts to promote, improve, and defend the health and well-being of all species and their environments. By fostering greater collaboration between veterinarians, physicians, and public health experts, the initiative seeks to gain a better understanding of zoonotic diseases, which can be transmitted between species.

Indonesia’s size and geography presents an uncommon challenge for public health workers and veterinarians alike. The world’s fourth-largest country, it is inhabited by about 230 million people living on 6,000 islands, and speaking 170 local languages. What’s more, most of the country’s 1.4 billion poultry are in small backyard flocks held by private citizens to feed their families.

The arrival of HPAI has tested Indonesia’s capacity to prevent and control an animal disease of major public health and economic importance. The goal of these efforts is to progressively reduce infections to poultry in order to reduce risk to people, but HPAI is currently considered endemic in 30 of the 33 provinces. The Tufts PDS/R project supports training and operations of surveillance and response teams in 165 districts across the islands Java, Bali, Sumatra, Kalimantan, and Sulawesi. These teams have already diagnosed and responded to HPAI outbreaks across the country. Over the next year, the project will provide refresher training to all current PDS/R teams while also expanding to an additional 150 districts on Sumatra, Kalimantan, and Sulawesi.

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About the Rockefeller Foundation

The Rockefeller Foundation was established in 1913 by John D. Rockefeller, Sr., to “promote the well-being” of humanity by addressing the root causes of serious problems. The Foundation supports work around the world to expand opportunities for poor or vulnerable people and to help ensure that globalization’s benefits are more widely shared. With assets of nearly $4 billion, it is one of the few institutions to conduct such work both within the United States and internationally.

About Cummings School of Veterinary Medicine

Founded in 1978 in North Grafton, Mass., the Cummings School of Veterinary Medicine at Tufts University is internationally esteemed for academic programs that impact society and the practice of veterinary medicine; three hospitals that treat more than 28,000 animals each year; and groundbreaking research that benefits animal, public, and environmental health.

Source: Tom Keppeler

Tufts University, Health Sciences

People with severe mental illness receive twice the benefit from an IPS (Individual Placement Support) program at establishing themselves in competitive employment, when compared to vocational services*, according to an article in The Lancet, this week’s issue.

IPS involves job searching based on the patient’s preference. It provides the patient and employer with continuing support from an employment specialist who works for the local mental health service.

Professor Tom Burns, Department of Psychiatry, University of Oxford, UK, and team carried out a study involving 312 patients across six centers – London, UK; Ulm-Guenzburg, Germany; Rimini, Italy; Zurich, Switzerland; Groningen, Netherlands; Sofia, Bulgaria. 156 of them received IPS while 156 received vocational services. They were followed up for 18 months. The researchers measured the difference between the percentages of patients who entered competitive employment from the two groups.

Here are some of the results:

– 55% of IPS patients worked for at least one day
– 28% of vocational services patients worked for at least one day

– 13% of IPS patients dropped out of the service
– 45% of the vocational services patients dropped out of the service

– 20% of IPS patients were readmitted to hospital
– 31% of vocational services patients were readmitted to hospital

The researchers say that the varying IPS success rates were directly influenced by local unemployment rates in the different centers.

“Our demonstration of the effectiveness of IPS in widely differing labor market and welfare contexts confirms this service to be an effective approach for vocational rehabilitation in mental health that deserves investment and further investigation,” the researchers concluded.

“Further progress will inevitably require new international partnerships, funding from a wide variety of sources, different research designs, a long-term focus to track vocational recovery, and inclusive communities prepared to restore equal rights of citizenship and value human strengths over deficits. Equally important will be the need for researchers to produce evidence for immediate use in developing policy and in sponsoring local evidence based programs,” wrote, Dr Geoff Waghorn, Queensland Centre for Mental Health Research, University of Queensland, Australia and Dr Paul Gold, University of South Carolina, USA, in an accompanying Comment.

*Vocational services are the standard psychiatric rehabilitation services that aim to train people to return to work (i.e. train and place as opposed to place and train). They use structured training such as IT training, interview training, time-skills and practice in sheltered settings. They are often day programs.

thelancet

Responding to the Queen’s speech today, ASH welcomed the promise of legislation to improve public health but expressed disappointment that the detail of the measures to protect children by tackling smoking have not yet been made clear. Overall ASH is optimistic that measures to further curb tobacco marketing will be included in the new health bill and that the government will resist pressures from business to weaken or stop the implementation of these policies.

ASH Director, Deborah Arnott said:

“We are pleased that the Government has announced that it will be bringing forward measures to improve public health but disappointed that it is unclear what exactly this will mean. A ban on the sale of tobacco from vending machines and the removal of tobacco products from public view in shops will lead to a significant decline in the number of young smokers taking up the habit. The public support the toughest possible measures to protect children from a life-long addiction to tobacco.

“There’s no time to waste. The government must make clear its intentions and publicise these as soon as possible. Every day of delay results in yet more children being lured into a habit that will ruin their health and shorten their lives. “

The DH consultation on the future of tobacco control received overwhelming backing for strong legislation from nearly 100,000 respondents, including many health professionals and most of Britain’s leading public health and welfare organisations.

ASH

STUTTGART, GERMANY (UroToday) – Apoptotic DNA fragments in serum of patients with muscle-invasive bladder cancer are of prognostic relevance.

The authors compared 45 patients with muscle-invasive bladder cancer and 45 patients with BPH. With the aim of RT-PCR, two DNA fragments were identified and found to be present in significantly higher levels in serum of patients with muscle-invasive bladder cancer compared to patients with BPH. Sensitivity was 96% and specificity 62%. Also, the apoptotic index was higher in patients with muscle-invasive bladder cancer. There was no correlation with tumor stage according to TNM.

The authors concluded that the presence of apoptotic DNA fragments in serum of patients with muscle-invasive bladder cancer is a negative prognostic phenomenon.

Abstract #P7.1

Presented by J. Ellinger, MD, et al., at the 60th Annual Congress of the German Urological Association (DGU) – September 24 – 27, 2008 – Stuttgart, Germany

Reported by Christian Doehn, MD, a Contributing Editor with UroToday

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Like horses running down the long stretch of a race track, two different artery-opening treatments appear to be running neck-and-neck when it comes to preventing stroke among people with clogged neck arteries and other health problems.

After three years, patients who had a minimally-invasive procedure were just as likely to suffer a stroke or heart attack, or to die, as those who had open-neck surgery.

The findings should help guide the treatment of patients who need to have one of the two carotid arteries in their necks un-clogged to reduce their risk of a stroke – but who face a high risk of complications during surgery because of other health issues. Such patients may do better with the minimally invasive option, called carotid stenting.

But the study, called SAPPHIRE, doesn’t settle the question for many other patients, for whom the open surgery – carotid endarterectomy – is a tried-and-true option.

The results, from 260 patients who were randomly assigned to one of the two treatments at 29 hospitals, are published in the April 10 issue of the New England Journal of Medicine by researchers from the University of Michigan Cardiovascular Center, Harvard University and others. The study was funded by Cordis, a Johnson & Johnson company, which had no role in the analysis of study data.

“Patients who are undergoing a procedure want to know that they’ll be protected long-term from stroke, and that the procedure is safe,” says Hitinder Gurm, M.D., the U-M interventional cardiologist who is the study’s first author. “This is the first study to suggest that stents do just as well long-term as surgery, in high-risk patients.”

The study’s senior and corresponding author is Donald Cutlip, M.D., executive director of clinical investigations at Harvard University’s Clinical Research Institute. SAPPHIRE was led by Jay Yadav, M.D., formerly at the Cleveland Clinic and now at Piedmont Hospital in Atlanta.

In all, 41 of the 143 patients who received carotid stents, and 45 of the 117 patients who had open surgery, suffered a heart attack or a stroke, or died, within the first three years. The two rates are statistically equivalent, showing no difference between the two treatments. About a third of those events were strokes, most of them minor.

The two procedures both aim to do the same thing: to reduce the chance that a patient will suffer a stroke because a blood clot forms in a narrowed, plaque-clogged carotid artery, and then travels to the brain.

Most people are familiar with the idea that clogged arteries near the heart can lead to a heart attack. But far fewer people know the risks related to carotid artery disease.

This is despite the fact that both heart (coronary) artery disease and carotid artery disease are caused by the same plaque-forming processes involving inflammation, cholesterol and genetics. Just as in the heart, most patients experience no symptoms from clogged carotids. As a result, many people don’t realize they have the disease until they suffer a stroke or mini-stroke.

As many as one in four American adults have some narrowing of the carotid arteries. About 5 percent of women over age 65 and a slightly higher percentage of men in the same age group have at least one carotid blockage that cuts off 50 percent of the opening through which blood can flow.

The greater the blockage, the higher the risk of stroke. People who have already had a stroke or mini-stroke that originated in their carotid arteries are at an extremely high risk of suffering another stroke, while those who have severe carotid blockages but no history of stroke have less risk.

Both groups of patients are often considered the best candidates for some sort of treatment, though Medicare will only cover stents for patients who have experienced symptoms of carotid artery disease. But the debate over whether surgery or stenting is best or safest has raged for years.

Stents, which are tiny wire-mesh tubes that can hold open a blocked carotid, have been seen as a less-invasive option, because they can be threaded up into the neck from a tiny incision in the arm or groin. But the stent procedure carries its own risk of stroke, unless a debris-catching device is deployed to intercept anything that breaks off from the wall of the artery while the procedure is under way. Such filters, called emboli protection devices, were used in the SAPPHIRE study.

Meanwhile, carotid endarterectomy operations have been performed tens of thousands of times each year for decades. The operation opens an incision in the neck below the jaw, allowing a surgeon to divert the blood flow temporarily while he or she opens the carotid and clears out the plaque. Sometimes a stretch of new blood vessel is sewn into place.

But as tried-and-true as the operation is, it can lead to complications among people who have heart failure, lung disease, a history of neck surgery or radiation therapy – or who are over age 80 or have had previous carotid artery treatment but have developed new blockages.

Such patients are called high-risk, and stents have been seen as a lower-risk option for them. But until now, it was not known whether they would get the same stroke-preventing benefit from a stent.

In the SAPPHIRE study, patients who had symptoms of their carotid disease – such as a mini-stroke, stroke or dizziness – could participate if one of their carotids had a blockage of 50 percent or greater. But those without symptoms could only participate if they had a blockage of 80 percent or more that had been discovered through an exam such as an ultrasound scan of the neck.

In all, three-year data was available on 260 of the 334 patients who were randomly assigned to one of the two treatments at the beginning of the study. Previous analyses of SAPPHIRE data have shown no difference between the two treatment groups after 30 days and one year. The main measure to compare the two treatments was a combination of stroke, heart attack or death from any cause, though each type of incident was also analyzed.

“Clinical trials are now under way to determine the relative risks and benefits of stenting and endarterect-omy in average-surgical-risk patients, and to compare different stent procedures,” says Gurm, an assistant professor of internal medicine at the U-M Medical School and the VA Ann Arbor Healthcare Center. He notes that two such trials are under way at U-M. “Outside of trials, I do not think a person with average surgical risk should undergo stenting. But for high-risk patients, we can now be certain that they will have a similar long-term outcome from stenting as they would have had from surgery.”

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Reference: New England Journal of Medicine, Volume 358, Number 15, April 10, 2008

Source: Kara Gavin

University of Michigan Health System

Researchers at Sunnybrook Health Sciences Centre have made a critical discovery in T cell development bringing immunologists one step closer to enabling the creation of tailored T cell therapy that could one day be used to treat patients with AIDS or other immune system deficiencies.

“For the first time we understand which sets of molecules are required to induce different types of T cells,” says Canada Research Chair and principal investigator Dr. Juan Carlos Z–iga-Pfl-ckerr, a senior scientist at Sunnybrook Research Institute who is also a professor in the Department of Immunology at the University of Toronto.

The immune system uses two main types of T cells, alpha-beta and gamma-delta, each with unique roles in protecting us from disease. The findings show that T cell progenitors will develop into mature gamma-delta T cells despite the absence of the Notch molecule, a molecule that Z–iga-Pfl-cker’s lab recently showed was essential for the early-stage development of both types of T cells.

Published today in the journal Immunity, the research is also the first to show at what developmental stage the two types of T cells become distinct lineages. The lead researcher, Maria Ciofani, a PhD student in Z–iga-Pfl-cker’s lab, used precise cell isolation techniques to show which molecular cues are needed, and when for each lineage development. Collectively, the work clarifies how both T cell types can be generated in the laboratory, thereby enabling further study directed at tailoring their unique functions to specific clinical needs.

Gamma-delta T cells in particular hold exciting clinical promise for their ability to orchestrate immunity to a broad range of foreign molecules; experiments in mice have shown that gamma-delta T cell injections can eliminate cancerous tumours, although much work remains to translate this research into viable clinical therapy.

Z–iga-Pfl-cker was recently identified by the prestigious Thomson Scientific Essential Science Indicators as one of the most cited researchers in the field of immunology for his landmark December 2002 paper in Immunity, which showed how to generate T cells from stem cells in a Petri dish. In addition to enabling Z–iga-Pfl-cker’s current work, this breakthrough discovery established a simple and effective way for other researchers to study T cell development, and has advanced this study in hundreds of labs around the world.

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Sunnybrook Health Sciences Centre is transforming health care through the dedication of its more than 10,000 staff members who provide compassionate and innovative patient focused care. An internationally recognized leader in women’s health, academic research and education and an affiliation with the University of Toronto distinguishes Sunnybrook as one of Canada’s premier health sciences centres. Sunnybrook specializes in caring for newborns, adults and the elderly, treating and preventing cancer, heart problems, orthopaedic and arthritic conditions and traumatic injuries. Toronto Sunnybrook Regional Cancer Centre is the comprehensive cancer program at Sunnybrook, a Cancer Care Ontario partner and fully affiliated with the University of Toronto.

Contact:Jennifer White

Sunnybrook Health Sciences Centre