Significant progress in women's health was made this summer when the U.S. Food and Drug Administration (FDA) approved the first vaccine to prevent cervical cancer. The vaccine was given the green light for use in younger women, as a way to protect against human papillomavirus (HPV), a sexually transmitted virus that causes cervical cancer.


"This is the first vaccine for a cancer ever developed," said Phyllis Greenberger, president of the Society for Women's Health Research and chair of the Partnership to Prevent Cervical Cancer, a coalition of American organizations and individuals dedicated to making the vaccine part of routine health care for all women in the United States. "Cervical cancer is the only cancer for which we know the cause and can provide a method of prevention that is successful in a vast majority of cases. This is a tremendous breakthrough that will save lives and reduce excess medical costs."


The FDA has deemed the vaccine safe and effective for girls and women ages nine to 26 and studies are underway to determine the vaccine's usefulness for women over the age of 26 and for boys and men. Other vaccines are also in development.


"The Advisory Committee on Immunization Practices (a federal panel of 15 experts) has recommended the HPV vaccine for females ages 11-12," explains Janet Gilsdorf, M.D., professor and director of pediatric infectious diseases at the University of Michigan Medical Center in Ann Arbor. "Females ages 13-26 should also be vaccinated."


The vaccine is specifically recommended for girls 11-12 because researchers discovered that the maximum benefit from the vaccine occurs when it is given prior to the first sexual experience. The vaccine does not work as well for those who have already been exposed to the virus, but most women will still benefit from getting the vaccine because they will be protected against other virus types contained in the vaccine.


There are many different types of HPV, but only a select few can cause cervical cancer, Gilsdorf said. The HPV vaccine currently available may help guard against diseases that are caused by HPV Types 6, 11, 16, and 18. HPV Types 16 and 18 cause 70 percent of cervical cancer cases, and HPV Types 6 and 11 cause 90 percent of genital warts cases.


Roughly 80 percent of women will be infected by HPV by the age of 50, according to the Partnership to End Cervical Cancer.


Despite this significant advancement for women's health, some issues remain surrounding the vaccine. "Access is always a concern for vaccines," says Gilsdorf.


The HPV vaccine requires three doses and the list price for each dose is $120. Some insurance companies will pay for the vaccine and Vaccines for Children (VFC), a federal program administered by the Centers of Disease Control and Prevention, will pay for HPV vaccination for children 18 years of age and under that are Medicaid eligible, uninsured, American Indian or Alaska Native.


Underinsured children, whose health insurance benefit plan does not include vaccinations, can also receive VFC-funded vaccinations for free if they are served by a Federally Qualified Health Center or Rural Health Clinic. Parents who want to know if their children are VFC eligible should talk to their doctor or contact a local health clinic.


Follow-up and compliance with the three-part vaccine may become an issue for some women, especially college-aged women who may not return to the doctor to get the complete vaccination.


For some parents, condoning the administration of a sexually transmitted disease vaccine in their pre-pubescent daughters may cause concern. Some parents may have a tough time accepting or imagining the sexual activity of their daughters.


If a woman has HPV or even cervical cancer, she may not realize it. In general, there are few to no symptoms of cervical precancers or early cancers. It may take years for an infection with HPV to turn into cervical cancer, although some cases progress more quickly. Catching the disease in the early stages is imperative to a good prognosis. This is why it is so important for women to have this disease on their radar screen.


Pap tests are still recommended as a crucial part of cervical cancer screening. They have dramatically reduced the number of cervical cancer deaths in the United States. The American Cancer Society currently recommends an annual pap test for all women, three years after the start of vaginal intercourse, but not later than 21 years of age.


Society for Women's Health Research (SWHR)

1025 Connecticut Ave. NW, Ste. 701

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What is believed to be the largest study of its kind for the genetic roots of inflammatory bowel diseases has suggested new links to Crohn's Disease as well as further evidence that some people of Jewish descent are more likely to develop it.


The study examined changes in DNA associated with the two most common forms of inflammatory bowel disease (IBD): Crohn's Disease (CD), which is most frequently marked by inflammation of the final section of the small bowel (ileum) and parts of the colon, and ulcerative colitis (UC), an inflammation of the internal lining of the rectum and colon.


Results of the study, published in this month's edition of Genes and Immunity, included information gleaned from 993 families with IBD, 244 of whom were Ashkenazi Jews. Up to 30 percent of people with IBD in the United States are estimated to have a family history of the condition, and about 25 percent of these families have both CD and UC in the family. People of Ashkenazi Jewish descent are at least twice as likely to develop a form of IBD and are more likely to have familial disease.


"This increased risk for some Jewish people makes our study and results especially significant since this is the first sample size of Jewish families, 244, that was large enough to identify novel gene regions for familial predisposition in this ethnic group," says Johns Hopkins gastroenterologist and genetic investigator Steven R. Brant, M.D., senior author of the study.


By analyzing common DNA variations known as single nucleotide polymorphisms, or SNPs, the team found evidence for genes causing familial Crohn's Disease in the study population specific to Ashkenazi Jewish families with CD on previously identified areas of chromosomes 1 and 3. They also identified a never-before-identified region of chromosome 13 that was shared by both Jewish and non-Jewish families with CD. Evidence for chromosomal regions that may be linked to UC on chromosome 2 and 19 for Jewish and non-Jewish families was also noted, according to Brant.


"What makes these results especially significant is not only the large sample size but also the method we used for screening, namely the use of a high-density, single-nucleotide polymorphism genome-wide linkage process, says Brant." The new process is 10 times faster than older methods at searching the number of variations across the genome, he added.


Up to now, Brant says, no gene regions implicated in IBD were specific to Ashkenazi families, and genetic evidence pointing to why Ashkenazi Jews are twice as likely to get the disorder was lacking. The two genetic regions identified on chromosomes 1 and 3 were specific to Ashkenazi CD and unrelated to known IBD genes.


Although further study is needed to narrow down which specific genes are the major players, Brant says it's already clear that they are in the right "neighborhood" to search for IBD/CD susceptibility genes.


The National Institute of Diabetes and Digestive and Kidney Diseases Inflammatory Bowel Diseases Genetics Consortium (NIDDK-IBDGC) that organized the study is a multi-center team of American and Canadian investigators established in 2002 to examine genetic links among IBD pedigrees.


The subjects were recruited through the six IBD genetic research centers of the NIDDK-IBDGC -- Cedars-Sinai Hospital in Los Angeles, Johns Hopkins Hospital, the University of Chicago, the University of Montreal, the University of Pittsburgh and the University of Toronto.


Genotyping was performed at the SNP Center at the Center for Inherited Disease Research, Baltimore, Md.


The study was funded by the NIDDK, branch of the National Institutes of Health (NIH). Other researchers who worked on this study include lead author Yin Shugart, Ph.D., Johns Hopkins Bloomberg School of Public Health; co-senior author Judy H. Cho, M.D., Yale University School of Medicine, New Haven, Conn. and additional researchers from University of Toronto, Toronto, Canada; University of Pittsburgh, Pittsburgh; Cedar-Sinai Medical Center, Los Angeles; Johns Hopkins University, Baltimore; University of Chicago, Chicago; University of Manitoba, Winnipeg, Manitoba, Canada; University of Sherbrooke Hospital, Fleurimont, Quebec, Canada; McGill University, Montreal, Quebec, Canada and University of Montreal, Quebec, Canada.


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Thiazolidinediones (TZDs) are a class of medications that are commonly prescribed to treat type-2 diabetes, while fibrates are a structurally-related class of medications that are prescribed to modulate lipid levels in both diabetic and non-diabetic patients to help reduce the risk of cardiovascular disease. These drugs work by binding to peroxisome proliferator-activated receptors (PPARs), with TZDs reducing insulin resistance and lowering the levels of cytokines that promote inflammation, and fibrates reducing low-density lipoprotein (LDL) and triglyceride levels and increasing high-density lipoprotein (HDL) levels to help prevent the development of cardiovascular disease. Another effect of TZDs and fibrates is to raise leptin levels, an effect that may reduce appetite. Recent studies also suggest that PPARs are expressed in the central nervous system, particularly in brain regions implicated in reward.


Two papers recently published in Biological Psychiatry now suggest that drugs that stimulate two different subclasses of PPARs, PPAR-a and PPAR-g, may play roles in the treatment of nicotine and alcohol addiction by acting in the brain.


The first study, by Mascia and colleagues, used a multi-pronged approach to demonstrate that nicotine's addictive effects can be counteracted by drugs that activate PPAR-?±. In both rats and monkeys, these drugs reduced nicotine intake and relapse to nicotine seeking after a period of abstinence. They also prevented nicotine from altering electrical activity and neurochemical levels in addiction-related brain areas.


"Although our research involved highly selective experimental drugs, there are medications (fibrates) used clinically for the treatment of high cholesterol and triglyceride levels, which are selective PPAR-?± ligands," further explained senior author Dr. Steven Goldberg. "Drugs that selectively affect PPAR-?± receptors, possibly including fibrates, might provide a valuable new approach to the treatment of tobacco dependence in humans."


In the second study, Stopponi and colleagues used pioglitazone to evaluate its effects on alcohol drinking, relapse-like behavior, and withdrawal in rats. Pioglitazone activates PPAR-g and is an FDA-approved medication for the treatment of type 2 diabetes.


Corresponding author Dr. Roberto Ciccocioppo detailed their findings, "We demonstrated that activation of PPAR-g receptors by pioglitazone potently reduces alcohol consumption in a rat model of excessive drinking. We also found that pioglitazone abolishes alcohol craving elicited by exposure to stress and prevented the expression of somatic signs of alcohol withdrawal."


"As we learn more about the brain, we are seeing a growing number of examples where medications developed initially for purposes unrelated to psychiatry may have new and otherwise unexpected applications within psychiatry. In this case, the identification of neural PPARs in reward circuits suggested new roles for PPAR stimulators. These new data in animal models suggest that TZDs might be promising new agents in the fight against addiction," commented Dr. John Krystal, Editor of Biological Psychiatry.


It is important to note that these exciting initial findings are only the beginning steps in a line of research that will need to be undertaken before TZDs or fibrates could be used in a clinical setting to treat people with addictions.


Sources: Elsevier, AlphaGalileo Foundation.

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ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of resuscitation devices and related software solutions, announced that the quick-acting staff of a pharmacy in Limerick, Ireland recently saved a man's life with an AED Plus® following a car accident. Fortunately for the patient, employees at DocMorris Pharmacy on William Street in Limerick had just received life-saving training on the AED a few days earlier.


Pharmacy manager Linda O'Brien said they were trained how to use the defibrillator on Tuesday and the accident happened right after lunch on Friday. "We were lucky the accident didn't occur a week earlier when we were not equipped with an AED."


It is believed the middle-aged man went into sudden cardiac arrest (SCA) while driving up the street and crashed his vehicle into an unmarked Garda (Irish police) car. Passersby alerted the pharmacy staff who rushed to the scene and retrieved their portable defibrillator as soon as they saw the victim's condition. Pharmacist Fatima Sadek used the AED Plus to help with CPR feedback and to deliver a shock until paramedics arrived. The man is expected to make a full recovery in a nearby hospital.


"We never thought we would have to use the AED so soon. The AED Plus, with its CPR feedback, guided us through every step of the way," said O'Brien. "I never realized how important AEDs were until the incident. Every business should have one."


According to Lynn Doyle, marketing manager for the Unicare Pharmacy Group, the parent company of the Limerick pharmacy, the firm's Rathborne Pharmacy in Dublin was their first store to have an AED installed. Unicare Pharmacy Limited is Ireland's largest pharmacy retail group with 72 pharmacies in 15 counties across Ireland.


"In 2008, a cyclist suffered heart failure just outside the Dublin pharmacy," she said. "An off-duty doctor who was jogging past knew we had a defibrillator and came to his aid. The AED re-started his heart and bought him some valuable time until emergency services arrived. There is no predicting when you will need to use one."


About the AED Plus


The ZOLL AED Plus is the first and only Full-Rescue AED that provides Real CPR Help®, which coaches rescuers with audio and visual prompts to the correct rate and depth of chest compressions during CPR. The AED Plus guides rescuers through the complete Chain of Survival helping all sudden cardiac arrest victims, not just those who need a shock. The AED Plus requires minimal training to operate and is ideal for the infrequent rescuer.


About Sudden Cardiac Arrest


SCA, an abrupt disruption of the heart's function, which causes a lack of blood flow to vital organs, claims more than 1 million lives worldwide each year. It is the leading cause of unexpected death in the world and strikes without warning. Currently, only about 5 percent of victims survive; 95 percent will die from SCA.

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The diabetes epidemic is devastating many areas of the world. In China, approximately 20 million people suffer from the disease - and the number keeps growing. To meet this massive health challenge, the Chinese government is encouraging researchers from all over the world to collaborate with Chinese scientists in the development of effective diabetes therapies.



To fund an innovative Quebec-Chinese research initiative in this area, the Minist??re du D?©veloppement ?©conomique, de l'Innovation et de l'Exportation from Quebec recently awarded a grant of $150,000 to Dr. Constantin Polychronakos of the Research Institute of the McGill University Health Centre (MUHC) in Montreal. The funding will be used to establish a partnership with Dr. Du, Director of the Pharmacology Institute of the Chinese Academy of Medical Sciences in Beijing. The collaboration will focus on a new therapeutic approach to preventing type 2 diabetes.



Contrary to popular belief, the pancreas is not the only insulin-producing organ of the body. The thymus also produces a small quantity of insulin. While insufficient to regulate blood glucose levels, this insulin "programs" the immune system to recognize the peptide as "self." In healthy people, this programming prevents pancreatic insulin from being destroyed by an immune reaction. Dr. Polychronakos has studied this mechanism for many years and has succeeded in creating a culture line of insulin-producing thymus cells.



His goal is to find a drug that would trigger these cells to secrete more insulin. This would theoretically increase the body's tolerance to the hormone and thus reduce the symptoms of diabetes. However, achieving this objective means testing approximately 100,000 different compounds with special high-performance drug screening equipment - precisely the technology that is available in Dr. Du's laboratory in Beijing.



The collaboration between Dr. Polychronakos and Dr. Du will allow each one to benefit from the other's technology. Their research initiative has enormous potential and international scope. The project is expected to get underway no later than fall, 2008.







Dr. Constantin Polychronakos is Director of the MUHC's Pediatric Endocrinology and Metabolism Division, Co-Leader of the Endocrinology, Diabetes, Nutrition and Kidney Diseases Axes of the Research Institute of the MUHCand Professor of Pediatrics and Human Genetics at McGill University.



This project is co-funded by the Minist??re du D?©veloppement ?©conomique, de l'Innovation et de l'Exportation, the Juvenile Diabetes Research Foundation, and the Government of the People's Republic of China.



The McGill University Health Centre (MUHC) is a comprehensive academic health institution with an international reputation for excellence in clinical programs, research and teaching. The MUHC is a merger of five teaching hospitals affiliated with the Faculty of Medicine at McGill University - the Montreal Children's, Montreal General, Royal Victoria, and Montreal Neurological Hospitals, as well as the Montreal Chest Institute. Building on the tradition of medical leadership of the founding hospitals, the goal of the MUHC is to provide patient care based on the most advanced knowledge in the health care field, and to contribute to the development of new knowledge. muhc.ca/
















The Research Institute of the McGill University Health Centre (RI MUHC) is a world-renowned biomedical and health-care hospital research centre. Located in Montreal, Quebec, the institute is the research arm of the MUHC, the university health center affiliated with the Faculty of Medicine at McGill University. The institute supports over 600 researchers, nearly 1200 graduate and post-doctoral students and operates more than 300 laboratories devoted to a broad spectrum of fundamental and clinical research. The Research Institute operates at the forefront of knowledge, innovation and technology and is inextricably linked to the clinical programs of the MUHC, ensuring that patients benefit directly from the latest research-based knowledge.



The Research Institute of the MUHC is supported in part by the Fonds de la recherche en sant?© du Qu?©bec.



For further details visit: muhc.ca/research.



The Montreal Children's Hospital is the pediatric teaching hospital of the McGill University Health Centre (MUHC). The institution is a leader in the care and treatment of sick infants, children, and adolescents from across Quebec. The Montreal Children's Hospital provides a high level and broad scope of health care services, and provides ultra specialized care in many fields including: cardiology and cardiac surgery; neurology and neurosurgery, traumatology; genetic research; psychiatry and child development and musculoskeletal conditions, including orthopedics and rheumatology. Fully bilingual and multicultural, the institution respectfully serves an increasingly diverse community in more than 50 languages. thechildren/

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After a series of comprehensive research studies and a governmental research initiative, a respected team of radiation biologists and antioxidant scientists at Premier Micronutrient Corporation has developed BioShield-Radiation® - a patented micronutrient formulation specifically designed to address oxidative stress produced by ionizing radiation.


Now offered for the first time direct to the public via the new bioshieldpill website and the only product of its kind on the market, BioShield-Radiation® contains a unique, proprietary combination of dietary and endogenous antioxidants which have each exhibited radiation protection capabilities. Completely safe and maximally effective in decreasing oxidative stress as demonstrated in numerous scientific studies, BioShield-Radiation® is recommended for:


- Patients undergoing medical or dental x-ray procedures, including CT, nuclear, mammography, and fluoroscopy


- Anyone regularly exposed to elevated levels of ionizing radiation such as healthcare, aviation, military and nuclear power plant personnel, as well as people living in high radon homes and environments


- Frequent fliers (on average, the amount of cosmic radiation roughly doubles with every 6500-foot increase in altitude)


In addition to being offered direct to the public, BioShield-Radiation® is now available for purchase by hospitals, imaging centers, physician practices and dental facilities as well.


Genesis of BioShield Radiation


The U.S. Pentagon's search for ways to protect its personnel from the adverse effects of radiation they might encounter led them to Premier Micronutrient Corporation (mypmcinside), co-founded by Dr. Kedar Prasad, the first person to receive a Ph.D. in radiation biology in the United States. Because of the company's unparalleled expertise in antioxidant science, it was encouraged to develop an approach to radiation protection on a biologic basis that entailed close research collaboration with the Department of Defense and NASA and which - among other important applications - ultimately led to the development of the BioShield-Radiation® pill.

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If you think heart disease is a disease of the middle aged, think again.


Experts recommend that cholesterol screening should begin as early as 20 years of age because it is a key indicator of heart-attack risk, and should be rechecked at least once every five years.


Atherosclerosis begins early, says Dr. Anand Rohatgi, cardiologist with UT Southwestern Medical Center's program in preventive cardiology. Even young adults and teens can show evidence of atherosclrosis, or hardening of the arteries.


If early screening reveals low levels of good cholesterol (HDL) or moderately high levels of the bad cholesterol (LDL), counseling is provided to help modify lifestyles. Those who fall into this category should be reevaluated every one or two years.


"Simple measures that can reduce cholesterol levels include decreasing the amount of saturated fat to less than 7 percent of total calories consumed each day," Dr. Rohatgi says. "Also, increasing the amount of soluble fiber by just 5 to 10 grams daily and limiting cholesterol intake to less than 200 milligrams per day are helpful."


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Hospice and palliative medicine investigators presented preliminary research findings at paper sessions held during the Annual Assembly of the American Academy of Hospice and Palliative Medicine, in collaboration with the Hospice and Palliative Nurses Association, on March 25- 28, 2009, at the Austin Convention Center in Austin, Texas.



Community Characteristics Predict Availability of Hospice (413-C)


Lead author: Maria J. Silveira, MD MA MPH, University of Michigan, Ann Arbor, MI


(Silveira has disclosed no relevant financial relationships.)



Objectives


1. Gain understanding on why availability of hospice is important to define and explore.


2. Describe the results of a study to explore availability of hospice.



I. Background. Hospice is underutilized by racial and ethnic minorities as well as elderly adults. Patient and provider knowledge and demand are widely believed to be the strongest predictors of hospice utilization; however, ready access to hospice may also be important. Still, the availability of hospice has yet to be described and its determinants understood.



II. Research Objectives. (1) To describe geographic variation in the availability of hospice in the United States; (2) To explore the community-level predictors of that variation.



III. Methods. We used data from Medicare to identify the location of US hospices and their service areas. Our outcome of interest was county-level availability of hospice defined according to the amount of geographic clustering of hospice measured using geospatial technology. We used multivariate regression to test the relationship between this outcome and county wealth (% households with incomes > $100,000) and education (% with a high school diploma), adjusting for confounding by race (% blacks), ethnicity (% Hispanics), age (% > age 65), population count, and area.



IV. Results. For every 1% increase in the proportion of households with incomes >$100,000, there was a 16% greater chance of being in the next highest category of hospice availability. For every 1% increase in high school education, there was a 24% greater chance of being in the next highest category. For every 1% increase in elderly adults in a county, there was a 10% lower chance of being in the next highest category. In testing for confounding, we found wealth, education, and age each influenced the strength, though not the significance, of the relationship between our predictors of interest and availability. There was no confounding by race and ethnicity.



V. Conclusions. The availability of hospice is greater in communities with larger proportions of wealthy, educated, and young residents.



VI. Implications for research, policy, or practice. To address disparities in the utilization of hospice, policy-makers may need to address inequities in the availability of hospice first.
















Management of Implantable Cardiac Defibrillators in Patients on Hospice: Results of a Nationwide Geographically Weighted Survey (311-B)



Lead author: Nathan Goldstein, MD, Mount Sinai Hospital, New York City


(Goldstein has disclosed no relevant financial relationships.)



Objectives


1. Gain understanding in current hospice practices with regards to management of implantable defibrillators for patients near the end of life.


2. Gain understanding in frequency with which patients on hospice receive shocks from their implantable defibrillator.


3. Identify core elements which should be included in formal policies relating to deactivation of implantable defibrillators.



I. Background. Implantable Cardioverter Defibrillators (ICDs) have been shown to prevent sudden death, but communication about deactivation in patients near the end of life is rare.



II. Research Objectives. To determine the prevalence of hospices with policies about ICD deactivation, the frequency with which hospice patients receive shocks from ICDs, and how often deactivation occurs.



III. Methods. National geographically weighted random survey of 900 hospices using a unique survey instrument.



IV. Results. A total of 416 hospices responded (54% of hospices with correct contact information). 79.6% of hospices reported that in the last year they admitted between 1 and 10 patients with an active ICD. Only 10.9% of hospices stated they had a policy which addressed deactivation. Hospices with a question on admission forms asking if a patient had an ICD were more likely to have a deactivation policy (OR, 4.6; 95% CI, 2.2-9.2). 58.3% of facilities reported that in the last year a hospice patient had been shocked while on hospice, and on average, 44.3% (SE, 2.9) of patients with ICDs have the shocking function deactivated. Hospices that have a formal policy addressing deactivation are more likely to have a higher mean percentage of patients have their devices deactivated compared to those without a policy (72.5% vs. 37.6%; P < .0001).



V. Conclusions. Hospices are admitting patients with active ICDs, and patients with these devices are being shocked at the end of life. Few hospices have formal systems in place to address deactivation, but those that do are more likely to have patients' devices deactivated.



VI. Implications for research, policy, or practice. Assuring that hospices have policies in place to address ICD deactivation may improve outcomes for patients. Elements to include in these policies will be addressed as part of this presentation, and sample policies will be distributed.




Filming the Family: Evaluation of a Documentary Film Designed to Educate Physicians About the Experience of Family Caregivers of Patients with Life-Threatening Brain Tumors (412-C)



Lead author: Michael W. Rabow, MD, University of California San Francisco


(Rabow has disclosed no relevant financial relationships.)



Objectives


1. Recognize the value of family caregivers in the care of patients with brain cancer.


2. Recognize the important role of physicians in supporting family caregivers.


3. Explain the benefit of documentary film in increasing clinician sensitivity to the needs of family caregivers.



I. Background. Neurosurgeons and other clinicians often pay little attention to the important role of family caregiving. Documentary film may be an effective way to increase empathy for family caregivers among clinicians caring for patients with brain cancer.



II. Research Objectives. To evaluate the efficacy of a documentary film about family caregiving to improve clinician sensitivity to the needs of family caregivers.



III. Methods. We produced a 48-minute documentary about the family caregivers of 4 patients with glioblastomas. Before and immediately after viewing the film, neurosurgery/oncology clinicians nationwide completed an evaluation of their awareness of and commitment to the care of family caregivers, with scores analyzed using paired t-tests. Viewers also completed an evaluation of the film using a 10-point Likert scale, with analysis by descriptive statistics.



IV. Results. For this study, the film was shown at 6 screenings nationwide in 2007 and 2008 with 49 viewers, including 32 (65.3%) neurosurgeons, neurosurgery residents, and medical students. The remaining viewers included nurses, social workers, and chaplains. Following the film, viewers were more likely to believe that family caregivers greatly impact the health of patients with brain cancers (P < .01) and that all families of patients with brain cancers should meet with a social worker (P < .01). After the viewing, respondents were less likely to believe that supporting family caregivers was primarily "someone else's job" (P = .01). Viewers strongly agreed that the film was an effective way to teach about family caregivers (mean Likert score = 8.75) and that all clinicians caring for patients with brain cancers should see the film (9.04).



V. Conclusions. A documentary film about family caregivers is an effective means to improve sensitivity among clinicians to the needs of family caregivers.



VI. Implications for research, policy, or practice. Using documentary film to increase sensitivity of physicians to the needs of family caregivers may be an effective way to support family caregivers and thus ultimately improve the care their loved ones receive at the end of life.



Teaching Family Carers About How to Support a Dying Relative at Home: Final Results from a Group Education Program (312-B)



Lead author: Peter L. Hudson, PhD RN, St. Vincent's & The University of Melbourne, Victoria, Australia


(Hudson has disclosed no relevant financial relationships.)



Objectives 1. Understand the importance of evidence-based family-centered palliative care. 2. Gain insight regarding the typical needs of family carers. 3. Learn about an effective strategy designed to prepare family carers for the role of supporting a dying relative.



I. Background. Despite the considerable body of evidence, which identifies that family carers of palliative care patients want much more support and guidance to prepare them for their role, there has been a shortage of evaluated interventions.



II. Research Objectives. A group education program (GEP) was developed to provide family carers with information, support, and strategies to assist them to care for a dying relative at home.



III. Methods. The GEP was conducted via three sessions at six palliative care services in regional and metropolitan Australia. Participants were required to complete self-report questionnaires: Time 1 was immediately before the program; Time 2 was immediately after the program; and Time 3 was 2 weeks after the program. The questionnaires included measures of Carer: Preparedness, Competence, Rewards, and Unmet Needs. Participants also completed a program evaluation form and the managers of the participating services were asked to report on their perceptions of the utility of the program.



IV. Results. Thirty-two education programs were conducted with a total of 156 family carers attending. The intervention had a statistically significant effect on preparedness, competence, rewards, and having needs met, from Time 1 to Time 2, which was maintained at Time 3. The overwhelming majority of family carers reported that the program was applicable, useful, and accessible. The utility of the program was also reinforced via positive feedback from the program facilitators and managers of the clinical sites.



V. Conclusions. The evaluation of the GEP for home-based carers demonstrated its effectiveness in meeting the needs of carers and also enhanced their competence and preparedness for caregiving. Carers also reported increased positive feelings related to their role.



VI. Implications for research, policy, or practice. Although further evaluation is recommended, from the feedback obtained, the program could be implemented into practice with a moderate level of additional resources.




Understanding Fatigue in Children with Advanced Cancer (314-B)



Lead author: Christina Ullrich, MD MPH, Dana-Farber Cancer Institute, Boston


(Ullrich has disclosed no relevant financial relationships.)



Objectives



1. Describe the experience of fatigue in children with advanced cancer.
2. Identify physical and psychological factors associated with suffering from fatigue.
3. Identify care team factors related to suffering from fatigue.



I. Background. Fatigue is a common yet poorly understood symptom in children with cancer.



II. Research Objectives. To describe fatigue in children with advanced cancer and to identify factors associated with suffering from fatigue.



III. Methods. Retrospective, cross-sectional survey conducted from 1997 through 2001 of 144 parents of children who died of cancer, cared for at Dana-Farber Cancer Institute/Children's Hospital Boston or Children's Hospitals and Clinics, St. Paul/Minneapolis (response rate, 64%).



IV. Results. By parent report, 96% of children experienced fatigue in the last month of life and nearly 50% experienced significant suffering from it. Although no specific type of cancer or treatment modality was associated with fatigue, there was a trend toward an association between suffering from cancer-directed therapy and suffering from fatigue (P = .05). Suffering from fatigue was also associated with suffering from pain, dyspnea, anorexia, nausea/vomiting, diarrhea, anxiety, sadness, and fear (P < .05). In multivariate analyses of symptoms associated with fatigue, suffering from nausea/vomiting (OR = 3.73; CI, 1.22-12.76; P = .03), anorexia (OR = 8.67; CI, 2.03-37.06; P = .004), and fear (OR = 4.63; CI, 1.81-11.85; P = .001) remained independent factors associated with suffering from fatigue. Suffering from fatigue was additionally associated with the experience of side effects from pain or dyspnea treatment (P < .05). Finally, children who suffered from fatigue were cared for by primary oncologists with fewer years' experience (mean, 7.7 years; SD = 4.9), compared to oncologists of children who did not suffer from fatigue (mean, 9.9 years; SD = 6.0; P = .023). Among children who suffered from fatigue, 18% received fatigue-directed treatment, and this was unsuccessful in 79% of children.



V. Conclusions. Fatigue is a common and multifactorial source of suffering in children with cancer at the end of life. Palliation of this symptom is rarely attempted, and when attempted, is rarely successful.



VI. Implications for research, policy, or practice. Increased attention to factors associated with suffering from fatigue, provider education, and the study of interventions aimed at ameliorating fatigue are urgently needed.



Patients Receiving Pediatric Palliative Care Consultations: A Prospective Multi-Center Cohort Study (310-A)
Lead author: Chris Feudtner, PhD MD MPH, Children's Hospital of Philadelphia


(Feudtner has disclosed no relevant financial relationships.)



Objectives
1. Describe the demographic and clinical characteristics of pediatric patients receiving palliative care consultations.



2. Explore the implications of the diversity of patients served by hospital-based pediatric palliative care consultation teams.



3. Examine the advantages and challenges of conducting multi-center clinical studies.



I. Background. While the number of hospital-based pediatric palliative care (PPC) teams is growing, scant information exists regarding patients referred for PPC consultations.



II. Research Objectives. To describe the demographic and clinical characteristics and outcomes of patients who received PPC consultations.



III. Methods. Prospective observational cohort study conducted at 6 sites in the United States and Canada, each with an established hospital-based PPC team. All patients served by the teams from January to March 2008 were eligible for enrollment, and subjects were observed for 3 months. Data abstracted from clinical records were entered into a common database.



IV. Results. 511 new (35.2%) or established (64.8%) patients received care from the 6 programs during the 3-month enrollment interval. 54.2% were male, 69.5% were identified as white, 7% as Hispanic, and 56.8% had public insurance. Regarding age, 4.7% were younger than one month, 12.5% were 1-11 months, 37.2% were 1-9 years, 30.1% were 10-18 years, and 15.5% were 19 years or older. 59.1% lived with both parents, and 72.4% had siblings. The predominant primary clinical conditions were genetic/ congenital (40.9%), neuromuscular static (24.3%) or progressive (18.2%), respiratory (12.9%), and gastrointestinal (10.0%), with cancers (19.7%) classified as hematologic (7.0%), solid tumor (7.0%), or brain tumor (5.7%). Most patients had chronic utilization of some form of medical technology, with gastrostomy tubes (48.9%) being most prevalent. At the time of consultation, the most common symptom was cognitive impairment (47.2%); somatic (21.9%), visceral (11.5%), or neuropathic pain (9.6%) affected 30.9% of the cohort. Patients were receiving many medications (mean 9.1). During 3-month follow-up, 18% of the cohort died (pending final follow-up data); the median time from enrollment to death was 23.5 days.



V. Conclusions. PPC teams serve a diverse cohort of children and young adults.



VI. Implications for research, policy, or practice. PPC teams should be prepared to manage a diverse patient population.


Notes:


AAHPM's membership includes more than 3,600 physicians and other medical professionals dedicated to excellence in hospice and palliative medicine and the prevention and relief of patient and family suffering. Since 1988, AAHPM has supported hospice and palliative medicine through advancement of clinical practice standards, fostering research, providing education, and through public policy advocacy. For more information about the 2009 Annual Assembly or membership in the Academy, contact AAHPM at 847/375-4712 or visit the Web site at aahpm.



Credentialed media representatives are welcome in the press room (room #15) at the Austin Convention Center. Contact Mary Louise Carr at 847/375-3688 or email MLCarrAAHPM to register for the meeting in advance.

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Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products , today announced that the United States Food and Drug Administration (FDA) has issued a 510(k) marketing clearance for the Evident™ Microwave (MW) Ablation System, intended for use in the ablation of nonresectable liver tumors.


This new system offers a procedural option for patients who are not candidates for surgical resection and have few remaining treatment options. Its introduction reinforces the commitment to the oncology market shown over many years by Covidien's Energy-based Devices (EbD) business unit, the world leader in advanced energy-based surgical systems.


The Evident MW Ablation System is intended for the coagulation of soft tissue during percutaneous, laparoscopic and open surgical procedures. The system uses microwave energy, emanating from the feed point of the radiating section of an antenna, to cause coagulation of the tissue. The microwave energy creates heat by generating friction through the vibration of water molecules. With microwave ablation, there is no current flow through the patient, eliminating the need for grounding pads.


"The recent FDA concurrence for the Evident MW Ablation System's intended use for the ablation of nonresectable liver tumors is a testament to the comprehensive evidence-based approach EbD takes in the development of our products," said Ned Cosgriff, M.D., Vice President, Medical/Clinical Affairs, Covidien EbD. "As with any new technology, particularly one involving medical devices, training is essential for a product to be successful in today's healthcare environment. With the recently granted FDA clearance, our Interventional Oncology professionals can now train healthcare providers in the safe and effective use of the Evident MW Ablation System for the specific indication of ablation of nonresectable liver tumors."


This major technological advance allows surgical oncologists, interventional radiologists, hepatobiliary surgeons and other medical specialists to perform percutaneous, laparoscopic or open surgical soft-tissue ablation, and to perform these procedures at speeds up to 60 percent faster than is possible with other ablation products. With the Evident MW Ablation System, ablations may be achieved in approximately 10 minutes. The speed and efficiency of the Evident MW Ablation System may mean less time in the operating or radiology suite for medical professionals and patients and less time under anesthesia for patients.


"As the only company to offer both microwave and radiofrequency ablation systems globally, we are proud to be the first microwave ablation company to receive FDA clearance for the ablation of nonresectable liver tumors," said Kerr Holbrook, Vice President, Global Marketing, EbD Interventional Oncology. "At EbD, the Interventional Oncology business is focused on improving patient outcomes through the safe and effective use of technology in the oncology setting. As a company, we are committed to executing this objective in full compliance with the regulatory guidelines established by the FDA."


ABOUT COVIDIEN


Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries.


covidien

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An interim analysis of the XCALIBr
(Xeloda in Combination with Avastin as First-Line Treatment for
HER2-Negative Metastatic Breast Cancer) trial suggested that first-line
therapy with oral Xeloda(R) (capecitabine) in combination with Avastin(R)
(bevacizumab) may offer clinical benefit in metastatic breast cancer
patients who have no prior history of treatment. These data were presented
at the 29th Annual San Antonio Breast Cancer Symposium (SABCS) in San
Antonio, Texas.



At the time of study analysis, 72% of enrolled patients experienced a
clinical benefit (a measure of response rate and stable disease) with
Xeloda plus Avastin. The combination regimen was well tolerated by
patients, with the majority of adverse events being mild or moderate.



"We are very encouraged by these data which suggest that oral Xeloda in
combination with Avastin may provide clinical benefit for women with
advanced breast cancer," said clinical trial investigator William J.
Gradishar, MD, Associate Professor of Medicine in the Division of
Hematology and Medical Oncology at Northwestern University Medical School.
"Although the medical community has made great strides in the treatment of
early-stage breast cancer, there is still an urgent need for novel
treatment strategies to improve outcomes in advanced disease, which
currently has a five-year survival rate of only 20 percent."



Breast cancer is the most common cancer among women, other than skin
cancer. It is the second leading cause of cancer death in women, after lung
cancer. According to the American Cancer Society, about 212,920 women in
the United States will be found to have invasive breast cancer in 2006 and
about 40,970 women will die from the disease this year. Currently, there
are an estimated 2 million women living in the United States who have been
treated for breast cancer.



"These promising interim Phase II results in advanced breast cancer
patients underscore the potential of combinations using cornerstone anti-
cancer therapies such as Xeloda," said Lars Birgerson, MD, PhD, Vice
President, Medical Affairs, Roche. "Roche is committed to supporting
ongoing clinical trial programs that explore the potential of Xeloda in
combination with targeted and anti-angiogenic therapies."



Mature data from the XCALIBr trial will be presented at a future major
medical meeting.



About the Study



The primary objective of the multi-center, single arm, Phase II trial
was to evaluate progression-free survival in chemotherapy-naive metastatic
breast cancer patients receiving first-line Xeloda/Avastin combination
therapy. The first phase of the study was designed to evaluate efficacy and
tolerability. Study participants were limited to female outpatients
diagnosed with HER2- negative metastatic breast cancer or locally recurrent
breast cancer who are age 18 and older and are not pregnant.
















In the study, patients received first-line therapy with Xeloda 1000
mg/m2 twice a day for 14 days with seven days off in combination with
Avastin 15mg/kg IV in three-week cycles until first progression or
intolerance to treatment. Once progression was documented, patients were
treated with second-line therapy of Avastin 10mg/kg IV every two weeks in
combination with either weekly paclitaxel 80 mg/m2 or vinorelbine 25 mg/m2
on four-week cycles. Clinical investigators chose whether the patient
received paclitaxel or vinorelbine.



In an interim study analysis of 103 patients from a total of 109
patients enrolled, 44 patients (42.7%) remained progression free on
first-line therapy with Xeloda plus Avastin and 21 patients (20%) had
progressed to second-line therapy after a median duration of 4.2 months of
treatment. Forty-three patients were off protocol for reasons not related
to adverse reactions.



Treatment with Xeloda plus Avastin produced a 72% clinical benefit, a
measure of response rate and stable disease. Specifically, the combination
regimen resulted in a 5% complete response and a 29% partial response for
an overall response rate of 34% (95% CI: 24.9-44); 38% of patients had
stable (non-progressed) disease following combination treatment.



The analysis demonstrated that treatment with Xeloda plus Avastin was
well tolerated in most patients. The most common grade 3 adverse events
were hand- foot syndrome (13%), a skin condition that is commonly seen with
fluoropyrimidine agents, and pain (10%). The only grade 4 toxicity reported
was pulmonary embolism (2%). In those patients who have died (18%), the
cause of death was breast cancer or other causes unrelated to study
medication.



About Xeloda



Xeloda is the only FDA-approved oral chemotherapy for both metastatic
breast cancer and adjuvant and metastatic colorectal cancer. Inactive in
pill form, Xeloda is enzymatically activated within the body; when it comes
into contact with a naturally occurring protein called thymidine
phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic
(cell-killing) drug. Because many cancers have higher levels of TP than
does normal tissue, more 5-FU is delivered to the tumor than to other
tissue.



A clinically important drug interaction between Xeloda and warfarin has
been demonstrated; altered coagulation parameters and/or bleeding and death
have been reported. Clinically significant increases in prothrombin time
(PT) and INR have been observed within days to months after starting
Xeloda, and infrequently within one month of stopping Xeloda. For patients
receiving both drugs concomitantly, frequent monitoring of INR or PT is
recommended. Age greater than 60 and a diagnosis of cancer independently
predispose patients to an increased risk of coagulopathy.



Xeloda is contraindicated in patients who have a known hypersensitivity
to 5-fluorouracil, and in patients with known dihydropyrimidine
dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with
severe renal impairment. For patients with moderate renal impairment, dose
reduction is required.



The most common adverse events (greater than or equal to 20%) of Xeloda
monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As
with any cancer therapy, there is a risk of side effects, and these are
usually manageable and reversible with dose modification or interruption.



About Roche



Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
rocheusa or roche.us.


Roche

rocheusa


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The American Association for Cancer Research, the world's oldest and largest cancer research organization, congratulates Harold E. Varmus, M.D., on his nomination by President Barack Obama to serve as the 14th director of the National Cancer Institute (NCI).


"Dr. Varmus will bring to the NCI an unrivaled appreciation for how basic science serves as the foundation for understanding healthy function as well as disease conditions," said Elizabeth H. Blackburn, Ph.D., president of the AACR. "His visionary leadership will allow NCI to continue leading the way in programs aimed at preventing disease, improving health and reducing suffering from cancer."


"This is a great day for cancer research. It is hard to imagine someone more qualified for this position," added Tyler Jacks, Ph.D., past president of the AACR. "Dr. Varmus has a tremendous wealth of experience, an abundance of good ideas and almost unlimited energy. The AACR looks forward to working with Dr. Varmus in the months and years to come."


"Cancer research is advancing at a staggering pace. Dr. Varmus' extraordinary vision and leadership will be vitally important in our efforts to further reduce cancer incidence and mortality," added Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the AACR. "As Dr. Varmus takes the helm of the NCI, the AACR is confident that we will accelerate the pace of discovery research and translational research, and thereby bring hope and improved survival to cancer patients everywhere."


Varmus, a Nobel Prize Laureate and former head of the National Institutes of Health, most recently served as president and chief executive officer of the Memorial Sloan-Kettering Cancer Center, New York.


He, along with J. Michael Bishop, M.D., and colleagues demonstrated the cellular origins of the oncogene of a chicken retrovirus, which led to the isolation of many cellular genes that normally control growth and development and are frequently mutated in human cancer. For this work, they won the 1989 Nobel Prize for Physiology or Medicine.


Varmus is also recognized for his studies of the replication cycles of retroviruses and hepatitis B viruses, the functions of genes implicated in cancer, and the development of mouse models of human cancer.


Varmus was named by President Clinton to serve as the director of the National Institutes of Health, a position he held from 1993 to 1999. He was appointed by President Barack Obama as co-chair of the President's Council of Advisors on Science and Technology. Additionally, Varmus served on the World Health Organization's Commission on Macroeconomics and Health from 2000 to 2002; is a co-founder and chairman of the Board of Directors of the Public Library of Science, a publisher of open access journals in the biomedical sciences; and chaired the Scientific Board of the Grand Challenges in Global Health at the Bill and Melinda Gates Foundation from 2003 to 2008 where he now chairs the Foundation's Global Health Advisory Committee. He is a member of the National Academy of Sciences and the Institute of Medicine. He has received the National Medal of Science, the Vannevar Bush Award and several honorary degrees and other prizes.


Varmus will succeed John E. Niederhuber, M.D., director of the NCI since 2006. In addition to his leadership at the NCI, over the course of his career, Niederhuber has supported the advancement of cancer research as a professor, cancer center director, National Cancer Advisory Board chair, external advisor to the NCI, grant reviewer and laboratory investigator.


Source
American Association for Cancer Research (AACR)

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The Pharmaceutical / Biotechnology Group at Frost & Sullivan is pleased to announce its 2008 Quarterly Analyst Briefing Presentation on the targeted therapies segment of U.S. breast cancer therapeutics market to be held on Tuesday, February 26, 2008 at 12:00 p.m. CST / 1:00 p.m. EST.


Physicians treating breast cancer use varying combinations of cytotoxic, hormonal and targeted therapies. Future research into treatment strategies will focus on drugs with clear therapeutic potential, as well as minimal side effect profiles. Specialized therapies such as monoclonal antibodies, angiogenesis inhibitors, and vaccines could make a significant impact through targeted mechanisms of action and minimized toxicities. Combining these innovative highly specific therapies with existing cytotoxic and hormonal therapies is rapidly becoming the standard of care for treating breast cancer.


This briefing will benefit executives in the pharmaceutical and biotechnology industries, healthcare executives, and individuals interested in trends and information on breast cancer or the area of oncology.


Highlights of the briefing include: An analysis of patient populations and statistics, a look into current treatment trends and strategies and an analysis on pipelines and ongoing research into targeted therapeutics.


"The booming success of the targeted therapeutics segment and the extensive benefits of these new therapies, alongside new treatment strategies with more effective combinations of chemotherapy and hormonal drugs, are expected to drive the demand for drugs in this market. It is estimated that the targeted therapeutics segment alone could undergo the most significant growth over the forecast period reflecting the increasing importance of this segment to the overall market," notes Frost & Sullivan Research Analyst Misty Hughes.


To participate, please e-mail Melina Trevino at melina.trevinofrost with the following information: your full name, company name, title, telephone number, e-mail, address, city, state and country. Upon receipt of the above information, a registration link will be e-mailed to you.


Frost & Sullivan, the Global Growth Consulting Company, partners with clients to accelerate their growth. The company's Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents.

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Fraud and abuse by some home health care providers contributed to a 44% rise in Medicare spending on home health care services over five years, according to a Government Accountability Office report released Friday, USA Today reports. The report reviewed home care payments between 2002 and 2006. The number of Medicare beneficiaries using in-home services increased by 17% to 2.8 million during that period and spending on home health care services reached $13 billion in 2006. According to the report, some home care providers exaggerated beneficiaries' medical conditions, while others billed the government for unnecessary services or care they did not provide. The study recommended that CMS consider performing criminal background checks on home care providers and developing new rules that make removing problem providers easier.

Senate Finance Committee ranking member Chuck Grassley (R-Iowa), who requested the report, said, "There's no excuse for Medicare officials neglecting payment problems," adding, "Every home health care dollar that's lost to fraud or improper payments is a dollar that doesn't go to necessary care and a better quality of life for older U.S. residents." Acting CMS Administrator Charlene Frizzera said the government "is committed to continually reviewing and refining our process to improve the Medicare program." She said Medicare is working to manage improper payments for home care services (Appleby, USA Today, 3/13).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Researchers at the University at Buffalo are beginning two new studies as part of an international effort to prevent type 1 diabetes.



The project, called Type 1 Diabetes TrialNet, involves researchers at 22 clinical centers in the U.S. and in centers in Canada, Europe, Australia and New Zealand. The investigators will identify 100,000 persons at risk of developing type 1 diabetes and test interventions to prevent the onset of the disease.



Teresa Quattrin, M.D., UB associate professor of pediatrics and chief of the Division of Endocrinology-Diabetes at The Women and Children's Hospital of Buffalo, where the Buffalo TrialNet clinical center will be located, is principal investigator in Buffalo.



The research is funded by a $172,364 grant from the National Institutes of Health.



Type 1 diabetes is an autoimmune disease in which the body's immune system attacks the beta cells in the pancreas that produce insulin (in contrast to type 2 diabetes, in which cells stop absorbing the insulin the body produces). Insulin is necessary to metabolize glucose and supply the body with energy.



Damage to the beta cells occurs over a period of years. When about 90 percent of the cells have lost the ability to produce insulin, the disease manifests itself, primarily in childhood, adolescence and young adulthood.



"The many years of this destructive process preceding the onset of type 1 diabetes represent a tremendous window of opportunity to prevent the disease," Quattrin said. "Via TrialNet, we can identify persons who are on the path to developing type 1 diabetes with simple blood tests."



In the initial phase of this project, called the Natural History Study, Quattrin and her team will screen people at increased risk for developing type 1 diabetes. Persons considered at risk and eligible to be screened fall into two groups: those 45 or younger who have a brother, sister, child or parent with type 1 diabetes; or those 20 or younger who and have a cousin, aunt, uncle, niece, nephew, half-sibling or grandparent with type 1 diabetes.



"The risk of any given child developing type 1 diabetes is 1 in 400," said Quattrin. "However, if there already is a relative affected by type 1 diabetes in the family, that risk increases significantly. For example, if a child has a sibling with type 1 diabetes, his or her own risk of developing type 1 diabetes increases to 1 in 100."



The first screening test will look for auto-antibodies associated with type 1 diabetes in the blood, an indication that the body's immune system may be attacking the insulin- producing cells in the pancreas, increasing the risk for developing diabetes.



Participants will be categorized into one of three risk groups, depending on the concentration of autoantibodies. This risk-assessment method is called "staging" and is considered to be very accurate.



Different preventative strategies are being planned depending on results of the staging.
















"Those determined to have less than 50 percent risk of developing type 1 diabetes within five years may be eligible to receive oral insulin in an attempt to halt the beta cell destruction process," Quattrin said. "Other trials for participants whose risk is considered greater than 50 percent are being proposed for FDA approval. All participants will be followed yearly or more often, depending on their risk group, to see if their immune function improves, remains unchanged or deteriorates."



The second study phase will involve collecting blood samples from families who have two affected siblings with type 1 diabetes (TRIG study) to study the genetic makeup of these families. "This is a very important and promising study," said Quattrin. "Learning what is causing certain families to have more than one affected child will provide information that is key to preventing the disease in the general population." Samples will be collected from affected children and up to two non-affected siblings and parents.



Quattrin and her team also are conducting a study in children and adolescents newly diagnosed with type 1 diabetes using an immune modulator called Enbrel, a drug that has been used to treat other autoimmune diseases such as rheumatoid arthritis. While this study is not part of TrialNet, Quattrin said she anticipates that the diabetes center at Women and Children's Hospital will be involved in similar studies as part of the TrialNet mission.



"The goal of this study is to slow the progression and/or halt the beta cell destruction in patients who already are diagnosed," said Quattrin. "After diagnosis, there is a period called partial remission, or a 'honeymoon period,' where the patient's pancreas recuperates the ability to make a significant amount of insulin. This study intervenes in this phase."







Individiuals interested in participating in any of these studies may contact Angela Clark, the project coordinator, email aclarkupa.chob.



The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York.



Contact: Lois Baker


University at Buffalo




View drug information on Enbrel.

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Clusters of heated, magnetic nanoparticles targeted to cell membranes can remotely control ion channels, neurons and even animal behavior, according to a paper published by University at Buffalo physicists in Nature Nanotechnology.



The research could have broad application, potentially resulting in innovative cancer treatments that remotely manipulate selected proteins or cells in specific tissues, or improved diabetes therapies that remotely stimulate pancreatic cells to release insulin.



The work also could be applied to the development of new therapies for some neurological disorders, which result from insufficient neuro-stimulation.



"By developing a method that allows us to use magnetic fields to stimulate cells both in vitro and in vivo, this research will help us unravel the signaling networks that control animal behavior," says Arnd Pralle, PhD, assistant professor of physics in the UB College of Arts and Sciences and senior/corresponding author on the paper.



The UB researchers demonstrated that their method could open calcium ion channels, activate neurons in cell culture and even manipulate the movements of the tiny nematode, C. elegans.



"We targeted the nanoparticles near what is the 'mouth' of the worms, called the amphid," explains Pralle. "You can see in the video that the worms are crawling around; once we turn on the magnetic field, which heats up the nanoparticles to 34 degrees Celsius, most of the worms reverse course. We could use this method to make them go back and forth. Now we need to find out which other behaviors can be controlled this way."



The worms reversed course once their temperature reached 34 degrees Celsius, Pralle says, the same threshold that in nature provokes an avoidance response. That's evidence, he says, that the approach could be adapted to whole-animal studies on innovative new pharmaceuticals.



The method the UB team developed involves heating nanoparticles in a cell membrane by exposing them to a radiofrequency magnetic field; the heat then results in stimulating the cell.



"We have developed a tool to heat nanoparticles and then measure their temperature," says Pralle, noting that not much is known about heat conduction in tissue at the nanoscale.



"Our method is important because it allows us to only heat up the cell membrane. We didn't want to kill the cell," he said. "While the membrane outside the cell heats up, there is no temperature change in the cell."



Measuring just six nanometers, the particles can easily diffuse between cells. The magnetic field is comparable to what is employed in magnetic resonance imaging. And the method's ability to activate cells uniformly across a large area indicates that it also will be feasible to use it in in vivo whole body applications, the scientists report.



In the same paper, the UB scientists also report their development of a fluorescent probe to measure that the nanoparticles were heated to 34 degrees Celsius.



"The fluorescence intensity indicates the change in temperature," says Pralle, "it's kind of a nanoscale thermometer and could allow scientists to more easily measure temperature changes at the nanoscale."



Pralle and his co-authors are active in the Molecular Recognition in Biological Systems and Bioinformatics and the Integrated Nanostructure Systems strategic strengths, identified by the UB 2020 strategic planning process.



In addition to Pralle, who has an adjunct position in the Department of Physiology and Biophysics in UB's School of Medicine and Biomedical Sciences, co-authors are Heng Huang and Savas Delikanli, both doctoral students in the UB Department of Physics, Hao Zeng, PhD, associate professor in the physics department, and Denise M. Ferkey, PhD, assistant professor in the UB Department of Biological Sciences.



The research was supported by the National Science Foundation and the UB 2020 Interdisciplinary Research Development Fund.

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CardioTech International, Inc (Amex: CTE) today announced that the Vision (TM) Cardiopulmonary Bypass (CPB) equipment is
being used at Fountain Valley Regional Hospital and Medical Center in Orange County, which has one of the nation's oldest
transfusion-free surgery programs.


The Vision (TM) CBP Equipment is manufactured and sold by Gish Biomedical, Inc., a wholly owned subsidiary of CardioTech. The
Vision CBP includes oxygenators, reservoirs, filters and Cardioplegia units, which are now considered mainstream components
in transfusion-free surgeries specifically targeted to Jehovah's Witnesses who adhere to a biblical admonition against
receiving blood.


The Los Angeles Times in its January 31, 2005 Health section featured a front page, multicolumn article focusing on the
growing trend towards transfusion-free cardiothoracic surgery, not just for Jehovah's Witnesses, but for elective surgeries
as well. Pope John Paul II was ill for two months with symptoms similar to mononucleosis or hepatitis, contracted from
transfusions he received after a 1981 assassination attempt.


Douglas Whittaker, President of Gish Biomedical commented, "We are gratified to have seen our equipment in use in one the
L.A. Times color photographs. Gish's cardiopulmonary products address a $500,000,000 annual market worldwide. We are pleased
to provide information concerning this matter as a public service. You can learn more about transfusion-free medicine at the
following websites: Jehovah's Witnesses health website:


noblood; Gish Biomedical website:


gishbiomedical; and the Society for the
Advancement of Blood


Management: sabm.


About CardioTech


CardioTech International, Inc. maintains operations in Wilmington, Massachusetts; Plymouth, Minnesota and Rancho Santa
Margarita, California. CardioTech focuses on developing, manufacturing and marketing devices to surgically treat
cardiovascular disease. Current revenue sources include patented polyurethanes, medical devices, contract manufacturing, and
disposables used during cardiopulmonary bypass procedures. CardioTech is currently conducting human clinical trials with a
synthetic coronary artery bypass graft that addresses a $1.5 billion annual market. Additionally, CardioTech has partnered
with Implant Sciences and CorNova to develop a drug-eluting stent that addresses a $1 billion international market.


CardioTech believes that this release contains forward-looking statements that are subject to risks and uncertainties. Such
statements are based on management's current expectations and are subject to facts that could cause results to differ
materially from the forward-looking statements. For further information you are encouraged to review CardioTech's filings
with the Securities and Exchange Commission.


Investor contact:

Aurelius Consulting Group:

Dave Gentry, 407/644-4256

daveaurcg


runonideasCardioTech International, Inc.
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PanGenex Corporation (Pink Sheets: PGXC) announces the product launch of LIPIDEME™, an all-natural nutraceutical formulated with scientifically proven ingredients and the first product on the market to combine the triglyceride-lowering power of Omega-3 fatty acids with the cholesterol lowering ability of phytosterols and tocotrienols - plus the free-radical fighting capacity of Coenzyme Q10 (CoQ10).


Dr. Eric J. Springer, Chiropractic Physician with Northeast Chiropractic states that "LIPIDEME is one of the most exciting products out there today. LIPIDEME is an easy and effective way to help reduce cholesterol and improve cardiovascular health. As a Physician I look for the highest quality when recommending products to my patients. I've experienced the results of LIPIDEME personally and they speak for themselves. LIPIDEME is the gold standard in natural cholesterol lowering supplements."


LIPIDEME is formulated with pharmaceutical grade fish oil that is over 86% pure Omega-3s; the highest content available without a prescription for heart, mental, joint and skin health. The Omega-3s in LIPIDEME are molecularly distilled and tested to ensure that there are no detectable levels of Mercury, PCBs, or other toxins or heavy metals. The US Food and Drug Administration and the American Heart Association all recommend the consumption of Omega-3 fatty acids from fish, and state that Omega-3s provide much needed protection for your heart.


LIPIDEME provides the proper amount of phytosterols to assist in naturally lowering the amount of cholesterol that is absorbed through food. Phytosterols are natural, plant derived compounds that when taken in appropriate amounts, block the absorption of cholesterol from food. Phytosterol administration has been proven to result in lower serum levels of bad cholesterol (LDL), yet show no reduction in good cholesterol, (HDL).


LIPIDEME contains tocotrienols, part of the vitamin E family, which are a 40-60 time more potent antioxidant than the common form of vitamin E, tocopherol. Research shows that delta and gamma tocotrienols inhibit cholesterol production in the liver. Tocotrienols do not effect liver health or rob the body of CoQ10.


LIPIDEME in formulated with CoQ10 which has been the subject of thousands of clinical trials and has been shown to be a potent antioxidant and to boost energy, especially in cardiac muscle tissue.


LIPIDEME can be purchased through the Internet at PanGenex. LIPIDEME is also commercially available through qualified practitioners across the country with new practitioners ordering the product daily. PanGenex anticipates practitioners, distributors and retail sales to increase as LIPIDEME is launched throughout the country.


(1) The statements in this press release have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.















Learn More about Dr. Eric Springer at:
northeastchiropractor


About PanGenex Corporation


PanGenex is a publicly traded corporation (PINK SHEETS: PGXC) and pursues business opportunities in the $60 billion dollar nutraceutical and dietary supplement industry. With a focus specifically on the cardiovascular health segment, PanGenex develops and markets sector leading, patented or patent pending, condition specific nutraceuticals and topical over-the-counter (OTC) drugs and personal care products. Each product is scientifically formulated to address specific health conditions throughout the population. Many of our products contain the purest grade of nutraceutical components available anywhere without a prescription. PanGenex markets products through healthcare practitioners throughout the U.S., fine retail establishments and the internet on websites such as PanGenex and Calgenex.


Cautionary Statement About Forward-Looking Statements


This press release contains "forward-looking statements," which are statements related to future, not past, events. In this context, the forward-looking statements often include statements regarding our goals, plans, projections and guidance regarding our financial position, results of operations, market position, pending and potential future acquisitions and business strategy, and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks" or "will." Any such forward-looking statements are not assurances of future performance and involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. These risks and uncertainties include, among other things, (a) general economic and business conditions, (b) the level of strategic partner incentives, (c) the future regulatory environment, (d) our cost of financing, (e) our ability to complete acquisitions and dispositions and the risks associated therewith, and (f) our ability to retain key personnel. These factors, as well as additional factors, could affect our forward-looking statements. We urge you to carefully consider this information. We undertake no duty to update our forward-looking statements, including our earnings outlook.

PanGenex

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A "new kind of medical practice is flourishing nationwide that offers to go to where the patients are -- whether a home, an office or a hotel -- to treat ailments as diverse as a sprained ankle or a bad case of bronchitis," the New York Times reports. Fees for home physician appointments can range from $250 to $450, as well as additional costs for tests and medications, with payment due at the time of appointments. In most cases, patients must pay the fees out of pocket, although some PPOs might reimburse members for between 70% and 100% of the cost.

Walter Krause -- founder of Inn-House Doctor, a company with 40 physicians on call in Boston, Chicago, Dallas, Houston, Las Vegas, Philadelphia, Phoenix and Washington, D.C., that provide home appointments -- said, "When you call, you can speak to a doctor in five minutes, and that doctor can be there with you within the hour. Where else do you get that kind of delivery?" According to the Times, the practice has increased in recent years as the "demand for primary care physicians outweighs the supply in many cities," hospital emergency departments "are becoming overloaded with nonemergency cases" and reimbursements for physicians have decreased.

Rick Kellerman, president of the American Academy of Family Physicians, said, "We have that perfect storm. The current system doesn't work well for patients or physicians," adding, "More doctors are coming up with new home business practice models. They're exasperated with paperwork and insurance regulation" (Alsever, New York Times, 9/23).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Patients who receive the CYPHER(R)
Sirolimus-eluting Coronary Stent were less prone to experience heart
attacks (Q-wave myocardial infarctions) or blood clots (stent thromboses)
than patients treated with the Taxus Stent, according to two-year data from
a prospective, randomized, multi-center study. The latest results from the
REALITY Trial were unveiled here today at the World Congress of Cardiology.


"Drug-eluting stents have made it possible for more patients to receive
less invasive treatments for cardiovascular disease," said Antonio Colombo,
M.D., from San Raffaele Hospital and Centro Cuore Columbus Hospital in
Milan, Italy, one of the REALITY investigators and the presenter of the
results. "As discussions over the safety of these devices take place,
studies such as REALITY, can help physicians select the best treatment
option for their patients."


Less than 1 percent (0.9 percent) of the patients in the CYPHER(R)
Stent arm of the REALITY Trial experienced stent thrombosis. In contrast,
2.5 percent of the patients in the Taxus Stent arm suffered a blood clot
(p=0.02).


In addition, patients treated with the CYPHER(R) Stent suffered a
Q-wave myocardial infarction (a heart attack affecting the full thickness
of the heart wall) much less frequently than those receiving the Taxus
Stent (0.1 percent vs. 1.5 percent; p=0.006).


Major adverse cardiac events or MACE, which in this study were defined
to include cardiac deaths, Q-wave myocardial infarctions, non-Q wave
myocardial infarctions (heart attacks that do not involve the full
thickness of the heart wall), target lesion revascularizations
(re-interventions to reopen an artery) using bypass surgery or angioplasty,
were also tracked. A composite of these did not show a statistical
difference between the two drug-eluting stents.


"These results underscore once again that not all drug-eluting stents
are created equal," said Dennis Donohoe, M.D., Vice President, Worldwide
Clinical and Regulatory Affairs, Cordis Corporation. "The unsurpassed
safety and efficacy of the CYPHER(R) Stent is consistently supported by a
robust clinical trial program that examine its performance in a broad range
of patients, including complex cases."


The CYPHER(R) Stent clinical trial program includes more than 60
studies, with many additional independent clinical trials, and hundreds of
publications in the most respected peer reviewed journals.


The REALITY Trial involved 1,386 moderately complex patients from 90
centers in Europe, Latin America and Asia. These patients were randomly
selected to receive either the CYPHER(R) Stent or the Taxus Stent. In the
end, the CYPHER(R) Stent was used in 684 patients and 970 artery blockages,
while the Taxus Stent was used in 669 patients and 941 artery blockages.
Cordis Corporation sponsored the REALITY trial.















About the CYPHER(R) Stent


The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat
more than two million patients with coronary artery disease. The safety and
efficacy of the device is supported by a robust clinical trial program that
includes more than 60 studies, inclusive of independent clinical trials,
that examine the performance of the CYPHER(R) Stent in a broad range of
patients.


Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent
is currently available in more than 80 countries and has the longest-term
clinical follow-up of any drug-eluting stent. The first next-generation
drug-eluting stent, the CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent,
was launched in Europe, Asia Pacific, Latin America and Canada in 2003.
CYPHER SELECT(TM) Plus, the first third-generation drug-eluting stent,
received the CE mark in June 2006 and will be made available in many
markets outside the United States on Sept. 20, 2006.


About Cordis Corporation


Cordis Corporation, a Johnson & Johnson company, is a worldwide leader
in developing and manufacturing interventional vascular technology. Through
the company's innovation, research and development, physicians worldwide
are better able to treat the millions of patients who suffer from vascular
disease. More information about Cordis Corporation can be found at
cordis.


Cordis Corporation has entered into an exclusive worldwide license with
Wyeth for the localized delivery of sirolimus in certain fields of use,
including delivery via vascular stenting. Sirolimus, the active drug
released for the stent, is marketed by Wyeth Pharmaceuticals, a division
of Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth
Pharmaceuticals.


Cordis Corporation

cordis


View drug information on Rapamune.

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Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical
company focused on oncology, announced positive incremental data from
its ongoing Phase 2 clinical trial of picoplatin in combination with
docetaxel and prednisone as first-line therapy for metastatic
hormone-refractory prostate cancer (HRPC). The expanded and updated results
continued to show that picoplatin can be safely administered with full-dose
docetaxel and prednisone, the standard treatment for HRPC, with no
neurotoxicity observed. In addition, reductions of prostate specific
antigen levels (PSA) of at least 50 percent were achieved in 78 percent of
evaluable patients. Normalized PSA levels were achieved in 26 percent of
patients.



"These data are very encouraging as they suggest that picoplatin can be
safely administered with full doses of docetaxel as first-line therapy in
the treatment of hormone-refractory prostate cancer," said E. David
Crawford, M.D., professor of surgery and radiation oncology, and head of
the Section of Urologic Oncology at the University of Colorado Denver and
associate director of the University of Colorado Comprehensive Cancer
Center in Denver. Dr. Crawford also is a member of Poniard's Clinical
Advisory Board. "I believe these early Phase 2 results may potentially
support a Phase 3 trial. A therapy with an improved safety and efficacy
profile would be important for patients with advanced prostate cancer, who
have a very poor prognosis and few effective treatment options."



The data were presented in a poster session (abstract # 211/poster
#211) during the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and
Cancer" in Geneva, Switzerland. Picoplatin, the Company's lead product
candidate, is a new generation platinum chemotherapy agent with the
potential to become a platform product addressing multiple indications,
combinations and formulations for the treatment of multiple solid tumor
indications.



Phase 2 HRPC Trial Design and Preliminary Results



In the ongoing Phase 2 trial, the efficacy and safety of intravenous
picoplatin (120 mg/m squared) administered every three weeks (21 days) in
combination with full-dose docetaxel (75 mg/m squared) with daily
prednisone (5 mg) as a first-line treatment are being evaluated in 30
patients with metastatic HRPC who have not received prior chemotherapy. PSA
response (defined as a PSA reduction of at least 50 percent from baseline)
is the primary endpoint; secondary endpoints include safety, response rate,
time to progression and overall survival. The trial completed enrollment in
December 2007.
















Results presented at the Symposium showed a PSA response of at least 50
percent in 78 percent of the 27 evaluable patients and also showed that the
combination of picoplatin and full-dose docetaxel can be safely
administered. Manageable and reversible neutropenia were the main
hematologic toxicities. In contrast to picoplatin monotherapy,
thrombocytopenia was less severe and less frequent in combination with
docetaxel. To date, no neurotoxicity has been observed in this study. These
findings confirm and extend earlier Phase 2 results presented at the 44th
Annual Meeting of the American Society of Clinical Oncology in May and
results from the Phase 1 trial presented earlier this year.



"We are encouraged by the PSA decreases observed with picoplatin in
combination with docetaxel to date and with the finding that picoplatin
continues to be well tolerated in this Phase 2 proof-of-concept trial,"
said Robert De Jager, M.D., chief medical officer of Poniard. "Additional
data from this ongoing study may support the advancement of picoplatin into
a Phase 3 clinical trial for HRPC. Our growing body of safety and efficacy
data also supports the potential for additional uses of picoplatin as a
combination therapy in the treatment of non-small cell lung and ovarian
cancers where platinum and taxane combinations are currently used."



About Picoplatin



Picoplatin has an improved safety profile relative to existing
platinum-based cancer therapies and is designed to overcome platinum
resistance associated with chemotherapy in solid tumors. It is being
studied in multiple cancer indications, combinations and formulations.
Picoplatin has been evaluated in more than 750 patients and has
demonstrated anti-tumor activity in multiple indications with less severe
kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is
commonly observed with other platinum chemotherapy drugs.



In addition to the ongoing Phase 2 clinical trial in HRPC, Poniard is
evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial,
known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell
lung cancer. This registration trial currently is being conducted under a
Special Protocol Assessment (SPA) from the U.S. Food and Drug
Administration and is evaluating overall survival as the primary endpoint.
Picoplatin is also being evaluated in a Phase 2 clinical trial in patients
with metastatic colorectal cancer. Oral picoplatin is being evaluated in a
Phase 1 clinical trial in solid tumors. The oral formulation of picoplatin
has the same active pharmaceutical ingredient as the intravenous
formulation. Picoplatin has not been approved by any regulatory authority
for use in humans.



About Poniard Pharmaceuticals



Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on
the development and commercialization of innovative oncology products to
impact the lives of people with cancer. For additional information please
visit poniard.



This release contains forward-looking statements, including statements
regarding the Company's business objectives and strategic goals, drug
development plans, timing and results of clinical trials and the potential
safety and efficacy of its products in development. The Company's actual
results may differ materially from those indicated in these forward-looking
statements based on a number of factors, including risks and uncertainties
associated with the Company's research and development activities; the
results of pre-clinical and clinical testing; the receipt and timing of
required regulatory approvals; the market's acceptance of the Company's
proposed products; the Company's anticipated operating losses, need for
future capital and ability to obtain future funding; competition from third
parties; the Company's ability to preserve and protect intellectual
property rights; the Company's dependence on third-party manufacturers and
suppliers; the Company's lack of sales and marketing experience; the
Company's ability to attract and retain key personnel; changes in
technology, government regulation and general market conditions; and the
risks and uncertainties described in the Company's current and periodic
reports filed with the Securities and Exchange Commission (SEC), including
the Company's Annual Report on Form 10-K for the year ended December 31,
2007 and its Quarterly Report on Form 10-Q for the period ended June 30,
2008. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. The Company undertakes no obligation to update any forward-looking
statement to reflect new information, events or circumstances after the
date of this release or to reflect the occurrence of unanticipated events.



(C) 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved.



Poniard and Poniard Pharmaceuticals are trademarks of Poniard
Pharmaceuticals, Inc.


Poniard Pharmaceuticals, Inc.

poniard

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