Categories
Cardiovascular
Diagnostics
Endocrinology
Health Insurance
Medical Devices
Mental Health
Nutrition
Oncology
Public Health
Sexual Health
Popular Articles
Natural Remedies

Call For Public Debates On Future Uses Of Stem Cells Lead By Bioethicists
More than 40 scientists, bioethicists, lawyers and science journal editors are calling on their colleagues, policy makers and the public to begin developing guidelines for the research and reproductive use of stem cell-derived eggs and sperm, even though such use may be a decade or more away.
generic viagra online
Serious Concerns Over Methods Used To Allocate Scarce Healthcare Res
Two papers published on bmj.com today raise serious concerns over the methods used to put a value on the benefits of different treatments in order to set healthcare priorities.
News of the day
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).
Public Health

AAKP Meets With Centers For Medicare And Medicaid Services Regarding Passage Of Mippa And Chronic Kidney Disease Education

On Tuesday, May 26, 2009, the American Association of Kidney Patients" (AAKP) Executive Director Kim Buettner and members of the AAKP Board of Directors met with staff members of the Centers for Medicare and Medicaid Services (CMS) regarding the passage of the Medicare Improvement for Patients and Providers Act (MIPPA) on chronic kidney disease (CKD) education. MIPPA provides for Medicare coverage of up to six sessions of education for individuals with CKD in stage 4. The education includes instructions on the management of co-morbidities, with the goal of delaying the need for dialysis and discussion on the treatment options available to patients for renal replacement therapy. Buettner told members of CMS AAKP is appreciative of the legislation and outlined important factors the Association believes should be considered. "We want to make sure patients are at the forefront of the minds of CMS staff members when they are drafting these laws," stated Buettner. "I think we were able to do that today by giving CMS staff members an opportunity to meet patients these laws will have a direct affect on." AAKP is a national non-profit organization directed by patients for patients. Started 40 years ago by six dialysis patients, AAKP"s mission is to raise awareness about kidney disease, educating patients, family members and the general public about the disease and its treatment options. In a letter, AAKP asked CMS to consider the following: - The legislation (MIPPA) calls for a discussion of available treatment options. AAKP encourages fair, objective and equal access for all patients and family members to information about all forms of treatment options, including but not limited to: home therapies (hemodialysis and peritoneal dialysis), in-center hemodialysis (thrice weekly, nocturnal) and palliative care. - The education delivered should be in agreement with patient and family centered care guidelines, which encourages providing health care information at the level the patient and family chooses. - AAKP also asks you to consider how often a patient can receive this course of education. Only receiving this series of education once during a lifetime is not appropriate for patients. A patient who receives this education before receiving a transplant could easily need additional education if the transplant fails years later. To read the complete letter AAKP sent to CMS, visit the AAKP Web site at www.aakp.org/public-policy/public-comments-correspondence or call (800) 749-AAKP for more information. AAKP


Add your comment:
Name:
Site address: http://
Your message:
Enter today\\\\'s date, 2 digits
(spam protection):

© Copyright 2009