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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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Sandra R. Gordon Wins Golden Trumpet Award From The Publicity Club Of Chicago
At the 50th Annual Trumpet Awards Luncheon at the Palmer House Hilton in Chicago, Sandra R. Gordon received one of the most coveted public relations awards from the Publicity Club of Chicago (PCC). As the director of public relations at the American Academy of Orthopaedic Surgeons (AAOS), Sandra was the lead visionary and creative force for their organization"s multi-faceted special event "Seventy-five Years of Orthopaedic Surgery".
News of the day
Few Retail Health Clinics Located In Low-Income Areas, Study Finds
Most retail health clinics are located in more affluent areas of the U.S., rather than in low-income, medically underserved neighborhoods, according to a study published on Monday in the Archives of Internal Medicine, the AP/Washington Times reports. For the study, researchers mapped 930 retail clinics operating in 2008 and used U.S. census data to evaluate the overall income and racial characteristics of the neighborhoods where clinics were located. In counties with at least one retail health clinic, researchers compared census areas with and without retail clinics. According to the study, 123 clinics were in communities classified by the federal government as medically underserved. Communities with clinics had lower percentages of black and Hispanic residents, lower poverty rates, higher homeownership rates and higher median incomes, according to the study.Ateev Mehrotra of the University of Pittsburgh said, "Many people have promoted retail clinics as a cure for access to care for the underserved," adding, "These findings show that"s unlikely to happen." Lead study author Craig Pollack of the University of Pennsylvania said the study"s results suggest financial incentives might be needed to bring clinics to low-income communities (Johnson, AP/Washington Times, 5/26).
Oncology

New Research Presented At EHA Congress Shows That Soliris(R) Significantly Reduced Hemolysis In Never-Transfused Patients With PNH

Clinical investigators observed that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), reduced hemolysis (red blood cell destruction) and improved symptoms in nine patients with paroxysmal nocturnal hemoglobinuria (PNH) who had received no blood transfusions prior to initiating Soliris therapy. In a separate study of 11 patients with PNH, researchers observed sustained platelet recovery with Soliris treatment in a subset of seven patients with thrombocytopenia (reduced platelet levels), indicating a likely reversal of platelet consumption with Soliris in these thrombocytopenic PNH patients. These and other data sets were presented on June 6 and 7 at the European Hematology Association Congress in Berlin. Soliris is the only therapy approved in the European Union, United States, Australia and Canada for the treatment of patients with PNH, an ultra-rare, debilitating, and life-threatening blood disorder. "All patients with PNH, including those who do not require transfusion and may appear to be stable, are at increased risk for blood clots, kidney dysfunction, pulmonary hypertension and disabling fatigue caused by hemolysis," noted Leonard Bell, M.D., Chief Executive Officer of Alexion. "Research presented at EHA is a sobering reminder of the clinical consequences of this progressive, ultra-rare disease. These data further underscore the clinical impact of Soliris for the treatment of patients with PNH, and also provide insight into the potential role of complement inhibition in addressing other complement-mediated diseases." Never-Transfused and Minimally Transfused Patients with PNH Abstract 0581 titled "Efficacy of the Complement Inhibitor Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients Never Transfused," was presented at a poster session at the EHA Congress on Saturday, June 6 by Dr. Antonio Risitano, Research Associate at the University of Naples in Italy. Published research shows that Soliris reduces hemolysis in patients with PNH who require minimal transfusions. (1) However, many patients with PNH do not receive blood transfusions and continue to experience hemolysis and its clinical consequences. In this analysis, investigators assessed the safety and efficacy of Soliris in the treatment of nine patients with PNH who required no transfusions prior to starting Soliris therapy. These "never-transfused" patients were enrolled in the Italian Early Access Program with at least one of the following conditions: severe anemia due to intravascular hemolysis; frequent paroxysmal crises; severe symptoms due to hemolysis; or thrombosis (life-threatening blood clots). All patients experienced a dramatic reduction in hemolysis following treatment with Soliris for a median of 16 months, as measured by a median reduction in LDH from 1,500 U/L before treatment to 356 U/L after treatment (p=0.008). Overall, hemoglobin levels increased significantly from 9.0 g/dL before treatment to 10.7 g/dL after treatment (p=0.0003), with a median increase of 2.0 g/dL. The investigator noted that patients reported a marked improvement in quality of life. No serious adverse events were reported. Investigators compared these results to a subset of 21 patients previously enrolled in eculizumab clinical trials who had received zero or one transfusion during the year prior to eculizumab treatment. These patients experienced a significant reduction in hemolysis following six months of Soliris therapy, with a median reduction in LDH from 2,030 U/L before treatment to 336 U/L after treatment (p Patients with PNH and Thrombocytopenia Abstract 0584 titled "Effect of Eculizumab Therapy on Thrombocytopenia in Patients with Paroxysmal Nocturnal Hemoglobinuria," was presented at a poster session at the EHA Congress on Saturday, June 6 by Ilene Ceil Weitz, M.D., Assistant Clinical Professor of Medicine, Jane Anne Nohl Division of Hematology, Keck School of Medicine of the University of Southern California. Dr. Weitz presented additional results from an ongoing prospective study to measure the effect of Soliris therapy on measures of inflammation and thrombin generation in patients with PNH. The study uses highly sensitive laboratory tests to analyze blood samples collected from patients with PNH prior to treatment with Soliris and prior to each dose during the following 90 days. Preliminary results presented at the American Society of Hematology Annual Meeting in December 2008 found that patients with PNH, only one of whom had been previously diagnosed with a blood clot, exhibited a hypercoagulable state (high risk of blood clots) prior to treatment with Soliris, as indicated by elevated levels of key inflammatory and pro-thrombotic measures, including D-dimers and thrombin-antithrombin (TAT) complex. (2) Among the 11 patients enrolled in this study, seven had thrombocytopenia with platelet counts below 100 x 109/L (range: 26 to 88 x 109/L) prior to Soliris treatment. A sustained platelet recovery above 100,000 occurred in four out of seven patients during treatment with Soliris for periods ranging from two to 20 months. Levels of D-Dimer and TAT were elevated in all of the patients with thrombocytopenia prior to treatment, and decreased following Soliris therapy. "These results suggest that in some patients with PNH, thrombocytopenia may be due to platelet consumption and not bone marrow failure," said Dr. Weitz. "The finding that Soliris reduces thrombin-mediated platelet consumption in these PNH patients may have implications for the treatment of patients with other complement-mediated diseases complicated by thrombocytopenia." Additional Data The following research was presented during a poster session at the EHA Annual Meeting on Saturday, June 6: - Abstract 0585: "Efficacy of the Terminal Complement Inhibitor Eculizumab Used Chronically in a Patient with Cold Agglutinin Diseases (CAD)," Dr. Alexander Rç¶th. - Abstract 0587: "Modification of the Standard Eculizumab Dose To Successfully Manage Intravascular Haemolysis Breakthrough in Patients with Paroxysmal Nocturnal Hemoglobinuria," Dr. Richard Kelly. The following research was presented in an oral presentation at the EHA Annual Meeting on Sunday, June 7: - Abstract 1110: "Eculizumab Reduces Pulmonary Hypertension Through Inhibition of Haemolysis-Associated Nitric Oxide Consumption in Patients with Paroxysmal Nocturnal Hemoglobinuria," Dr. Anita Hill. The following research was presented in an oral presentation at the EHA Annual Meeting on Sunday, June 7: - Abstract 1114a: "Successful Pregnancy Outcome in Paroxysmal Nocturnal Hemoglobinuria on Long Term Eculizumab," Dr. Richard Kelly. About PNH Patients with PNH suffer from hemolysis (red blood cell destruction) which leads to thromboses (blood clots), disabling fatigue, anemia, impaired quality of life, pulmonary hypertension, shortness of breath, recurrent pain, kidney disease and intermittent episodes of dark-colored urine (hemoglobinuria). (3, 4) PNH is an ultra-rare blood disorder that strikes people of all ages, with an average age of onset in the early 30s. (5) Approximately 10 percent of all patients first develop symptoms at 21 years of age or younger. (3) PNH develops without warning and can occur in men and women of all races, backgrounds and ages. PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years. (6) It is estimated that approximately one-third of patients with PNH do not survive more than five years from the time of diagnosis. (6) PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS). (7,8,9) In patients with thrombosis of unknown origin, PNH may be an underlying cause. (3) More information on PNH is available at http://www.pnh.com. About Soliris Soliris has been approved by the U.S. Food and Drug Administration (March 2007), the European Commission (June 2007), Health Canada (January 2009) and Australia"s Therapeutic Goods Administration (February 2009) as the first treatment for all patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder defined by hemolysis, or the destruction of red blood cells. All four jurisdictions reviewed and approved their respective marketing applications for Soliris under their priority review or accelerated assessment procedures, and all four have designated Soliris as an orphan drug. More information on Soliris is available at http://www.soliris.net. 1. Bessler M, Schrezenmeier H, MaciejewskiJP, et al. Significant disease burden in paroxysmal nocturnal hemoglobinuria patients with lower levels of hemolysis, mild anemia and minimal transfusion: clinical improvement with eculizumab therapy [abstract]. Blood. 2007; 110 (11): A840. 2. Weitz IC, Ghods M, Rochanda L, et al. Eculizumab therapy results in rapid and sustained decreases in markers of thrombin generation and inflammation in patients with PNH [abstract]. Blood. 2008;112:A407. 3. Parker C, Omine M, Richards S, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106 (12):3699-3709. 4. Hill A, Richards S, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2007;137:181-92. 5. Sociç© G, Mary J Yves, de Gramont A, et al. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. Lancet. 1996; 348:573-577. 6. Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995; 333:1253-1258. 7. Wang H, Chuhjo T, Yasue S, Omine M, Naka S. Clinical significance of a minor population of paroxysmal nocturnal hemoglobinuria-type cells in bone marrow failure syndrome. Blood. 2002;100 (12):3897-3902. 8. Iwanga M, Furukawa K, Amenomori T, et al. Paroxysmal

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