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INDIANAPOLIS A new incisionless procedure, approved by the U.S. Food and Drug Administration last year, can help gastric bypass patients lose unwanted pounds they have regained since their initial weight-loss surgeries.

Bariatric surgeons at St. Francis Hospital Health Centers are among the first in Indiana to offer StomaphyX. The outpatient procedure uses a tube passed through the mouth and no surgical incisions.

During the procedure, approximately 12 to 20 H-shaped, staple-like fasteners are placed strategically in the stomach to create pleats in the tissue and to reduce the size of the stomachs pouch.

recreates the patients smaller stomach, causing the patient to feel full quicker and experience further weight loss, said Jonathan Mandelbaum, M.D., surgical co-director of the St. Francis Weight Loss Center. This is currently the only endoscopic or non-surgical way to reduce the size of the stomach after gastric bypass surgery. It is far less risky than a surgical revision of gastric bypass.

Mandelbaum said the key advantages of the precision include no incisions or scars, less pain, a lower rate of complications compared to the traditional revisional bariatric surgery
and a quicker recovery.

Following the procedure, patients follow a traditional post-bariatric surgery diet, but have no physical activity restrictions.

Good candidates for StomaphyXare those who have undergone gastric bypass for obesity, have regained some of the weight they had lost, are compliant with their diet, continue to exercise regularly and do not feel full early during meals, Mandelbaum said.

The procedure can give patients a tool to help them achieve their weight-loss goal and prevent obesity-related problems. We still depend on patients being compliant with exercise and diet for this procedure to be successful, Mandlebaum said.

The St. Francis Weight Loss Center, an American Society for Metabolic Bariatric Surgery Center of Excellence, also provides gastric bypass, Lap-BandTM and gastric sleeve procedures for the surgical management of obesity.
Contact the center by calling 317-782-7525, or visit StFrancisHospitals.org/weightloss.

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Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. (AP)
The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and the serrano peppers often confused with them, or dishes made with them such as fresh salsa.
But the big question is how those who love hot peppers would know where the chiles came from, especially in restaurant food.
re going to have to ask the person youre buying it from, said Dr. David Acheson, the FDAs food safety chief, who is advising restaurants and grocery stores to know their suppliers and pass that information to customers.
The big break in an outbreak that now has sickened nearly 1,300 people came on Monday, when FDA announced it had found the same strain of salmonella responsible for the outbreak on a single Mexican-grown jalapeno in a south Texas produce warehouse.
Tomatoes had been the prime suspect for weeks. And while those now on the market are considered safe to eat, health officials still havent exonerated them from causing illnesses when the outbreak began in April.
The pepper discovery threatened to paralyze that industry, too. Chile production is a $500 million crop in New Mexico alone, which produces most of the U.S. crop, state agriculture commissioners wrote the FDA on Thursday.
Fridays move clearing U.S. peppers came because clusters of illnesses around the country all seem to be tracing back to Mexican jalapenos, though not all sold through the McAllen, Texas, produce warehouse, Acheson said.
Domestically grown products are not tracing back at all to the outbreak, he said in an interview with The Associated Press. On Monday, we didnt know exactly where they all were coming from. Today were certain these are coming from Mexico.
FDA inspectors are on the farm that grew the only tainted pepper discovered so far, trying to determine where else it sent a harvest that began in April, Acheson said. The farm is large, but the question now is whether it harvested enough to be responsible for such a geographically large outbreak.

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Trius Appoints Paul Truex to Board of Directors. World churches urge UN act on Zimbabwe quot. T help it from being a sad day, but the hundreds of mourners who attended a private mass and memorial service for Tim Russert did their best to point out the most shining moments of a life well lived. WEDNESDAY, June HealthDay News A drug already approved to reduce the risk of breast cancer in high risk women also seems to cut the risk for other women. Raloxifene turned out not to have any effect on heart disease mortality risk, but it did reduce the risk of invasive breast cancer by percent, which translates into. The new analysis looked more specifically at raloxifenes effect on breast cancer and found a percent lower incidence of invasive ER positive tumors, but no effect on noninvasive breast cancer or invasive ER negative breast cancer.

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brMost U.S. medical schools are failing to address conflicts of interest caused by pharmaceutical industry marketing. Only 21 of 150 medical schools surveyed by the American Medical Student Association (AMSA) have strong policies (those graded A or B), according to the AMSA PharmFree Scorecard released recently.
AMSA collaborated with The Prescription Project, an industry watchdog group working to eliminate conflicts of interest in medicine, to develop a rigorous methodology and an interactive Web site that evaluates each schools policies in 11 areas. The AMSA PharmFree Scorecard (http://www.amsascorecard.org) offers a comprehensive look at conflict-of-interest policies across the country, as well as an in-depth, school-by-school look at policies that govern industry interaction with medical school faculty and trainees.
The AMSA PharmFree Scorecard evaluates restrictions on gifts, paid speaking for products, acceptance of drug promotion samples, interaction with sales representatives, and industry-funded education, among other criteria. Top-ranked (A') schools include: Mount Sinai School of Medicine (New York), the University of Pittsburgh Medical Center, the Uniformed Services University of the Health Sciences (Maryland), the University of California Los Angeles David Geffen School of Medicine, the University of Pennsylvania School of Medicine, the University of California Davis School of Medicine, and the University of California San Francisco School of Medicine.
Fourteen respondents received a (9 percent); 4 received a (3 percent); 19 received a (13 percent); and 60 received an (40 percent). Schools that declined to submit policies and schools that did not respond to repeated requests for policies received an automatic Twenty-eight respondents received a grade of In Process because their policies are currently under review or revision.
Pharmaceutical industry marketing to doctors has been estimated at $28 billion to $46 billion per year, with additional promotion by the medical device industry. This equates, conservatively, to $35,000 per year in marketing directed at each physician, on average. More than 100,000 pharmaceutical sales representatives regularly visit U.S. physicians, providing free lunches, gifts, medication samples and carefully-selected medical literature to promote their products. These presentations and personal relationships are designed to influence doctors to prescribe more drugs and more expensive drugs and have often become a substitute for objective medical evidence.
It is time to extricate marketing practices from medical education, says Dr. Brian Hurley, AMSAs national president. There is substantial evidence that marketing shapes physician prescribing habits. By eliminating the gifts and the misleading information that pharma reps currently bring into our schools, hospitals and academic medical centers, physicians will be able to better practice evidence-based medicine. And that translates into better care for our patients.
s Scorecard is meant to be not only a yardstick for measuring U.S. medical school conflict-of-interest policies, but also a guide for medical schools working toward adopting stronger and more practical policies, continues Hurley.
In April, the Association of American Medical Colleges (AAMC) proposed sweeping recommendations calling for medical schools to adopt strong conflict-of-interest policies to address industry interactions. The AAMC recommendations affirm reforms that the Prescription Project and AMSA have actively promoted. The AMSA PharmFree Scorecard, along with an escalating push for policy reform by the AAMC, students, physicians, consumer groups, and federal and state policymakers is a clarion call for low-scoring schools to take action.
The schools that earned and scores are to be commended for setting a high bar and aggressively moving forward to ensure medical education, training and patient care is free of commercial bias, says Robert Restuccia, executive director of The Prescription Project. While we still have a long way to go, we are optimistic that the growing momentum for reform will change the landscape and there will be great improvement next year.
The Prescription Project offers toolkits to help medical schools create strong conflict of interest policies in many of the areas identified in the AMSA PharmFree Scorecard, including: the provision of gifts, meals and pharmaceutical samples, ghostwriting, support for continuing medical education, and drug and medical device procurement. Prescription Project toolkits are available at http://www.prescriptionproject.org.
Launched in 2002, AMSAs PharmFree Campaign guides medical students in organizing to advocate for evidence-based rather than marketing-based prescribing practices, the removal of conflicts of interest and global access to essential medicines. AMSA provides toolkits, talks and training institutes to help medical students advance these goals. For more information, please visit http://www.pharmfree.org.
About the American Medical Student Association
The American Medical Student Association (AMSA), with more than a half-century history of medical student activism, is the oldest and largest independent association of physicians-in-training in the United States. Founded in 1950, AMSA is a student-governed, non-profit organization committed to representing the concerns of physicians-in-training. With more than 67,000 members, including medical and premedical students, residents and practicing physicians, AMSA is committed to improving medical training as well as advancing the profession of medicine. AMSA focuses on four strategic priorities, including advocating for quality, affordable health care for all, global health equity, enriching medicine through diversity and professional integrity, development and student well being.
American Medical Student Association
About the Prescription Project
The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and works to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers.

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April 8, 2008- Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today that a study published in the April 1 issue of the International Journal of Radiation Oncology*Biology*Physics - also known as the Red Journal - demonstrates that the CyberKnife® Robotic Radiosurgery System can serve as a non-invasive means for delivering high dose rate (HDR) brachytherapy dosing. The study supports the CyberKnife System's clinical flexibility in treating prostate cancer and expands the non-invasive options available to clinicians and patients.
HDR brachytherapy has been shown to be an extremely effective approach for treating prostate cancer, with substantial clinical evidence supporting its usage. Nevertheless, the required insertion of multiple catheters into the prostate, where they remain for the duration of the procedure (typically 1-3 days), makes it an invasive procedure.
This study demonstrates the CyberKnife System's ability to non-invasively deliver complex HDR-like radiation dose sculpting to the prostate, without the need for hospitalization or anesthesia, maximizing patient comfort and convenience. Early clinical outcomes of the study show a rapid reduction in prostate specific antigen (PSA) levels with minimal short-term side effects.
"HDR brachytherapy is an effective, accepted treatment for prostate cancer, but adoption has been limited because it is a difficult procedure for clinicians to deliver and for patients to undergo," said Donald B. Fuller, M.D., radiation oncologist, CyberKnife Centers of San Diego and Radiation Medical Group, and principal investigator in the study. "Our study concluded that CyberKnife radiosurgery can offer the benefits of HDR brachytherapy non-invasively on an outpatient basis that is both easy to deliver and comfortable for patients."
This study, titled 'Virtual HDRsm CyberKnife Radiosurgery for Localized Prostatic Carcinoma: Dosimetry Comparison with HDR Brachytherapy and Preliminary Clinical Observations' supports the CyberKnife System's clinical flexibility and demonstrates its capability to create either a uniform distribution of radiation across the prostate or a pattern of dose that is similar to HDR brachytherapy. The System's ability to track the location of the prostate, detect its position and correct the treatment beam angle continually throughout treatment ensures that either type of plan can be delivered accurately, accounting for the motion of the prostate during the treatment. The CyberKnife System gives clinicians a variety of non-invasive treatment delivery options, allowing them to customize the treatment to each patient's specific case.
"We are pleased to have published support of the CyberKnife System's diverse capabilities in prostate cancer planning and look forward to further clinical evidence following the publication of long term follow-up studies," said Eric P. Lindquist., senior vice president and chief marketing officer of Accuray.
Explanation of HDR Brachytherapy
HDR brachytherapy is a procedure commonly used in the treatment of prostate cancer. The procedure involves the insertion of catheters into the prostate gland, and then the delivery of a series of radiation treatments through these catheters. A computer-controlled machine forces a seed containing a high energy radioactive source into the catheters one at a time, and then controls how long this seed remains in each of the catheters. This method allows different regions of the prostate to receive different doses of radiation (i.e., regions of the prostate expected to have large numbers of tumor cells receive higher doses of radiation than other parts of the prostate that may have a smaller amount of tumor cells).
About the CyberKnife® Robotic Radiosurgery System
The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system designed to treat tumors anywhere in the body non-invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife System to deliver high-dose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.
About Accuray
Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a non-surgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more than 40,000 patients worldwide and currently more than 125 systems have been installed in leading hospitals in the Americas, Europe and Asia. For more information, please visit www.accuray.com.

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Amgen (NASDAQ: AMGN) announced that results from several preclinical and clinical trials investigating cancer treatment will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2008 in San Diego between April 12-16, 2008. Data will be presented on pipeline compounds: AMG 102, AMG 386, AMG 479, AMG 655 and motesanib diphosphate (AMG 706).
At AACR, Amgen will present data from studies investigating the tumor attacking potential of these products alone or in combination with other therapies. These early studies have provided the biologic evidence to allow Amgen to launch a suite of exploratory Phase 1b/2 programs with these five molecules, across 15 tumor types with more than 30 clinical trials currently underway or planned.
These data underscore our ongoing exploration of key biological processes that influence the growth of cancer cells including angiogenesis, apoptosis and growth regulation, said David Chang, M.D., vice president, Global Oncology Development at Amgen. In addition, Amgen is actively pursuing identification of biomarkers that will help the company make better and earlier decisions about pipeline compounds, and enable targeted application of specific therapies to the patients who are more likely to benefit from treatment with them.
Selected Presentations of Interest
Anti-Angiogenesis
A program focused on the development of molecules that will interdict the abnormal process of new blood vessel formation.
Combined treatment of angiopoietin and VEGF pathway antagonists enhances antitumor activity in preclinical models of colon carcinoma.
Overview: Researchers combined AMG 386 with either bevacizumab or motesanib diphosphate (AMG 706) to explore inhibition of the VEGF/VEGFR pathways.
Abstract No. 1113 (Sunday, April 13, 2008, 1:00 PM - 5:00 PM)
In-vitro activity of motesanib diphosphate, an inhibitor of VEGFR, PDGFR and Kit tyrosine kinases, against imatinib-resistant Kit mutations.
Overview: Researchers tested the activity of motesanib diphosphate (AMG 706) a small molecule inhibitor of VEGFR, PDGFR and Kit, against primary oncogenic and imatinib-resistant Kit mutations in Gleevec(R)-resistant gastrointestinal stromal tumors.
Abstract No. 4887 (Tuesday, April 15, 2008, 1:00 PM - 5:00 PM)
Modulation of radiation response by motesanib diphosphate in models of head and neck squamous cell (HNSCC) carcinoma.
Overview: Researchers explored the benefit of adding AMG 706 to radiation therapy in HNSCC models.
Abstract No. 5764 (Wednesday, April 16, 2008, 8:00 AM - 12:00 PM)
Cancer Cell Apoptosis
A program focused on the development of highly selective therapies to induce cancer cell death (apoptosis).
Positron emission tomography (PET) measurement of death receptor 5 (DR5) receptor occupancy (RO) using (64)Cu-labeled AMG 655 in colo205 xenografts.
Overview: Researchers evaluated the potential for PET to measure DR5 RO non-invasively using (64)Cu-labeled AMG 655 in an AMG 655- sensitive xenograft model (Colo205).
Abstract No. 3162 (Monday, April 14, 2008, 1:00 PM - 5:00 PM)
AMG 655, a monoclonal antibody agonist directed against Death Receptor 5, induces apoptosis in human colon carcinoma cell lines and its therapeutic potential is enhanced in combination with chemotherapeutic agents.
Overview: Researchers evaluated the anti-tumor potential of AMG 655 when it is combined with irinotecan or 5-flurouracil in a colon cancer model.
Abstract No. 1326 (Sunday, April 13, 2008, 1:00 PM - 5:00 PM)
AMG 655, a fully human agonistic antibody against Death Receptor 5, enhances the anti-tumor activity of gemcitabine in MiaPaCa2/T2, a pancreatic cancer model.
Overview: Researchers evaluated the anti-tumor potential of AMG 655 when it is added to gemcitabine in a pancreatic cancer model.
Abstract No. 3999 (Tuesday, April 15, 2008, 8:00 AM - 12:00 PM)
Growth Regulation
A program focused on targeting cellular pathways that regulate cell pre-production, survival, migration and invasion which cancer cells often escape.
Exploratory biomarkers in the HGF/SF: c-Met axis: preclinical and clinical results.
Overview: Examination of exploratory biomarkers that may help determine treatment response in several types of cancers.
Abstract No. 2804 (Monday, April 14, 2008, 1:00 PM - 5:00 PM)
AMG 479, a fully human anti-IGF-1R monoclonal antibody, inhibits IGF-1 induced phospho-Akt and enhances the antineoplastic activity of cyclophosphamide in vivo
Overview: Examining pathway activation in ongoing Ewings sarcoma trial.
Abstract No. 4001 (Tuesday, April 15, 2008, 8:00 AM - 12:00 PM)
Domain-specific mechanisms of receptor inhibition by AMG 479, a fully-human IGF1R targeted antibody
Overview: Inhibition of tumor growth with AMG 479 and other L2 domain antibodies versus CR and FnIII-1 antibodies in vivo using two different tumor models.
Abstract No. 3994 (Tuesday, April 15, 2008, 8:00 AM - 12:00 PM)
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com.
Forward Looking Statements
This news release contains forward-looking statements that are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgens most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgens most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of April 3, 2008 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

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