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Loan Repayment Legislation Includes Physical Therapists As Frontline Providers
Legislation to establish a Frontline Providers Loan Repayment Program that includes physical therapists was introduced Tuesday by Representative Bruce Braley (D-IA). The Access to Frontline Health Care Act of 2009 (HR 2891) would encourage physical therapists to practice in underserved areas, says the American Physical Therapy Association (APTA).
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Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
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Lymphoma Research Funded By Millennium Pharmaceuticals Inc./Lymphoma Research Foundation
The Lymphoma Research Foundation (LRF) is pleased to announce that the 2009 Millennium Pharmaceuticals, Inc./Lymphoma Research Foundation Clinical Investigator Career Development Award has been awarded to Kai Fu, MD, PhD, Associate Professor at the Nebraska Medical Center in Omaha, Nebraska.
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New Survey Highlights Growing Concern About Risk Of Infection In Cancer Patients And Emerging Antibiotic Resistance

Amgen (Nasdaq: AMGN) announced the results of a national Harris Interactive, Inc. survey indicating that the vast majority of oncologists and infectious disease (ID) specialists are highly concerned about the negative impact infection may have on treatment outcomes in chemotherapy patients, as well as emerging antibiotic resistance. Nearly all oncologists surveyed (92 percent) believe it is important for cancer patients to prevent infections to achieve successful treatment outcomes. Antibiotic resistance is a growing concern among the majority of physicians surveyed, with 96 percent of ID specialists and 79 percent of oncologists reporting an increase in antibiotic-resistant infections in cancer patients over the past five years. Both groups of physicians report methicillin-resistant Staphylococcus aureus (MRSA) infections as the most commonly observed in chemotherapy patients. Cancer patients are at a higher risk for infection due to a compromised immune system caused by both the cancer and chemotherapy treatment. Neutropenia, a low white blood cell count, is a common and potentially dangerous side effect in patients receiving strong chemotherapy. It can lead to a heightened risk of infection that can require hospitalization and be life-threatening. Each year, 60,000 cancer patients are hospitalized for chemotherapy-induced neutropenia, and a patient dies every two hours from this complication. Neutropenia also can potentially disrupt chemotherapy treatment, including both dose delays and dose reductions. Studies show that for certain types of cancer, chemotherapy produces the best long-term results when patients receive the full dose on schedule. "The survey findings show that one in four chemotherapy patients report having an infection during treatment, with more than a third requiring a second course of antibiotics," said Sean Harper, M.D., chief medical officer and head of Global Development at Amgen. "Infections associated with cancer treatment are increasing and are often serious, highlighting the need for a program to improve infection control and appropriate antibiotic management in these high-risk patients." To help raise awareness of the risks and impact of infections in cancer patients, Amgen is joining forces with the Centers for Disease Control (CDC) Foundation, and the Divisions of Healthcare Quality and Promotion and Cancer Prevention and Control at CDC on a three-year initiative to provide res and educational tools to help cancer patients, their caregivers and healthcare professionals. The initiative includes the development of evidence-based curricula for healthcare providers on infection control for cancer patients and appropriate antibiotic stewardship, and an interactive online education tool for patients on what to expect from treatment, as well as how to prevent and manage infection during treatment. "Programs to improve infection control in cancer patients, whose immune systems may be compromised by chemotherapy, will aid in saving the lives of these high-risk patients," said Charles Stokes, president and CEO of the CDC Foundation. "This initiative will bring together experts in oncology and infectious disease to raise awareness of this public health concern, and reduce the risk of infections, and ultimately, related deaths." Survey Result Highlights: Infections among chemotherapy patients are fairly common. -- Nearly one in four patients surveyed (24 percent) had an infection in the last 12 months while receiving chemotherapy treatment. Of these patients: -- 61 percent had more than one infection; -- virtually all took at least a week to recover; -- 22 percent reported taking four or more weeks to recover; -- 52 percent had to go the emergency room due to an infection; -- 42 percent were hospitalized, spending on average nine days in the hospital; and -- 43 percent experienced chemotherapy treatment interruption. -- ID specialists report seeing an average of 36 chemotherapy patients with an infection in a typical month. -- 57 percent of ID specialists and 28 percent of oncologists have observed methicillin-resistant Staphylococcus aureus (MRSA) infections as the most common infection in chemotherapy patients. Antibiotic resistance is a growing concern. -- Nearly all ID specialists (91 percent) report being very or extremely concerned about emerging antibiotic resistance in cancer patients. -- More than half of all patients (51 percent) are extremely or very concerned about antibiotic resistance. -- The issue of antibiotic resistance is the least likely to be discussed between physicians and patients, with 26 percent of oncologists (or nurses in their practice) discussing the issue before a cancer patient starts chemotherapy. Oncologists believe antibiotics are overused in preventing infections. -- 58 percent of oncologists believe antibiotics are overused in an effort to prevent infections in chemotherapy patients. -- Approximately half of ID specialists and oncologists surveyed said that antibiotics are effective at minimizing the risk of infection. -- There is general consensus among both ID specialists and oncologists (7 in 10) that washing hands frequently, avoiding sick people and using proper food handling techniques are effective strategies in minimizing a chemotherapy patient"s risk for infection. Physicians are concerned about the impact of infections in cancer patients. -- 87 percent of ID specialists are extremely or very concerned about the impact of infections on overall outcomes for chemotherapy patients, including overall survival and disease-free survival. -- Nearly half of cancer patients are not even aware that chemotherapy puts them at greater risk for an infection, and significant minorities of patients do not realize that an infection may in fact negatively impact the outcomes of their chemotherapy treatment. -- 36 percent disagree or strongly disagree that their chances for successful cancer treatment could be lower due to a dose reduction and/or delay in their chemotherapy schedule; -- one out of four patients believes it doesn"t matter if they have to take a break from their chemotherapy schedule, because they can just start back up again later; and -- almost one-quarter of patients (22 percent) believe it doesn"t matter if their doctor lowers the dose of chemotherapy treatment, because the doctor can always increase the dose later without any effect on overall treatment. Survey Methodology The survey was conducted by Harris Interactive, Inc. an independent market research and polling organization, with support from Amgen Inc. The survey included 430 interviews with cancer patients who are currently undergoing chemotherapy or who have undergone chemotherapy in the past 12 months, 150 oncologists and 151 infectious disease specialists. Data was collected from March 20, 2009 through April 15, 2009. Methodology: Oncologists and Infectious Disease Specialists Physician samples were drawn at random from the AMA master file of oncologists and infectious disease specialists. The AMA list was then matched to the Harris Interactive Online Physician Panel (HIPP) by ME number. Oncologists and infectious disease specialists on the AMA list who matched the HIPP were then included in the sampling frame and recruited to participate via e-mail invitation. Specialists in the AMA random draw who were not members of the HIPP were invited to participate via first-class mail. All e-mail and first-class mail invitations included a URL and password for one-time use to allow participants to log on to the Internet and participate in the survey research. Methodology: Patients Patients who were currently undergoing chemotherapy or had completed chemotherapy within the past year were recruited using the Harris Interactive Chronic Illness Panel (CIP). Patients were recruited to participate via e-mail invitation, which included a URL and password for one-time use to allow participants to log on to the Internet and participate in the survey research. 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 science"s 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 people"s lives. Amgen


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