June 30, 2008

• Bosentan (Tracleer®) Receives Positive EU Opinion For Treatment Of Patients With Mildly Symptomatic WHO Functional Class II PAH
  (Actelion) -- The CHMP recommended that the European Commission approve bosentan (Tracleer®) for the treatment of PAH in WHO Functional Class II (FC II) patients based on the EARLY study results. The extension of the indication recommended by CHMP reads: "Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1)." The European Commission decision is expected within the next 2-3 months.
  

• New Drug Application For Inhaled Treprostinil Submitted To The U.S. Food And Drug Administration
  (United Therapeutics) -- United Therapeutics Corporation and its wholly-owned subsidiary, Lung Rx, Inc., announced today the submission of a New Drug Application to the U.S. Food and Drug Administration for marketing approval of an inhaled formulation of treprostinil (ITRE) for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disease.
  

• Woman Needs New Lungs, Heart, In Her Fight To Stay Alive
  (Olwein Daily Register) -- DeAnn explained her younger sister Kari, age 27, and mother of four, is suffering from arterial pulmonary hypertension, a condition that was diagnosed around Thanksgiving 2006. Kari had become ill after the birth of her fourth child in 2005, complaining of shortness of breath. Over the next year various medical appointments did not reveal anything until her condition worsened with frequent fatigue.
  

• Using Combination Therapies In The Treatment Of PAH: What's On The Horizon?
  (Medscape) -- Although measurable improvements have been observed using the approved PAH treatments as monotherapy, it is not surprising that no single agent affecting 1 pathway can produce consistent or continued improvement. Similar to the approach used to treat other chronic diseases with multiple pathologic mechanisms such as heart failure, cancer, and systemic hypertension, utilizing combination treatment to target as many of these aberrant pathways as possible for PAH makes mechanistic sense.
  

• Disclosure of Organ Transplant Risks: A Question of When, Not If
  (Newswise) -- University of Pennsylvania School of Medicine physicians and bioethicists are calling for a new, more standardized way for patients in need of organ transplants to be informed of the risks they face. If adopted, their policy recommendations could promote greater equity in how organs are allocated while restricting patients' abilities to "cherry-pick" the best organs.
  

• Lupus Patients Need More Devotion To Sunscreen
  (HealthNewsDigest) -- Physicians need to step up their efforts to convince lupus patients to protect themselves from the sun, according to Gerlinde Obermoser, MD, and Bernhard Zelger, MD, of Innsbruck Medical University in Austria, in an editorial in Lupus.
  

• Online Services Let Patients Seek A Second Opinion From Home
  (USA Today) -- Online second-opinion services offer patients consultations from specialists based on the medical records that they fax, mail or send via the Internet.
  

• Jury Hears Closing Remarks In Fen-Phen Trial
  (Lexington Herald-Leader) -- The closing arguments in the case - now in its seventh week - took all day Monday to complete. The jury will begin deliberations Tuesday.
  

• New Source Of Heart Stem Cells Found
  (AFP) -- Researchers in the United States have discovered a new group of stem cells that can give rise to heart muscle cells, known as cardiomyocytes, according to a study published Sunday.
  

• Teen Awaits Life-Saving Phone Call
  (Click 2 Houston.com) -- He was diagnosed with primary pulmonary hypertension when he was 3 years old. His lungs don't function properly.
  

• Fen-Phen Case Nears Climax
  (Cincinnati Enquirer) -- The defendants are accused of defrauding Alvey and 439 others out of $65 million when they represented them in a civil suit filed more than 10 years ago in Boone Circuit Court against American Home Products, the drug maker.
  

• How To Find The Best Medical Treatment
  (LA Times) -- Know your way around the Internet, arm yourself with statistics and don't be afraid to speak up.
  

• Study Concludes That Bosentan (Tracleer®) Demonstrates Benefits In Patients With Mildly Symptomatic WHO Functional Class II Disease
  (Actelion) -- Professor Nazzareno Galié of the University of Bologna, Italy and lead investigator commented: "The EARLY trial demonstrates that without treatment, even mildly symptomatic patients experience PAH progression within a short period of time. In contrast, treatment with bosentan significantly delayed PAH progression while improving hemodynamic parameters."
  

• Canadian Scientists Deliver On Promise Of Stem Cell Therapy For Lung Disease
  (CNW) -- Two Quebecers suffering from pulmonary hypertension, a rare but debilitating lung disease, were treated in Montreal with their own gene-modified stem cells. This experimental treatment was administered at the Jewish General Hospital's Centre for Pulmonary Vascular Disease.
  

• Defense Rests In Diet-Drug Case
  (Louisville Courier-Journal) -- Nearly six weeks after the trial started, the defense finished its case yesterday and prosecutors will be done early today. The federal jury will hear closing arguments Monday and could begin deliberating later that day or early Tuesday.
  

•   Ikaria's INOflo (Nitric Oxide) For Inhalation To Be Officially Approved In Japan
  (EarthTimes) -- INOmax(R), in conjunction with ventilatory support and other appropriate agents, is used for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.
  

• Acetazolamide For Monge's Disease: Efficiency And Tolerance Of 6-Month Treatment
  (redOrbit) -- Conclusions: Acz reduces erythrocytosis and improves pulmonary circulation in Monge's disease without adverse effects. Its implementation as a chronic treatment for this disease appears efficient and safe.

• Clinical Outcomes Of Pulmonary Arterial Hypertension In Carriers Of BMPR2 Mutation
  (redOrbit) -- Rationale: Germline mutations in the gene encoding for bone morphogenetic protein receptor 2 (BMPR2) are a cause of pulmonary arterial hypertension (PAH). Objectives:We conducted a study to determine the influence, if any, of a BMPR2 mutation on clinical outcome.
  

• A New Valve With No Open-Heart
  (Ivanhoe Newswire) -- During the procedure, a catheter is inserted through a small puncture in the groin. The new aortic valve -- made from the heart tissue of a cow -- is sewn inside a metal stent, then fed up through the catheter and into the heart. The stent pushes the patient's faulty aortic valve to the side and holds the new valve in place.
  

• Belimumab Effective In Patients With Serologically Active Systemic Lupus Erythematosus
  (Doctors Guide) -- In the 3-year extension phase of a phase 2 study, roughly half of all patients with serologically active SLE had a significant improvement in symptoms as measured by the SLE Responder Index.
  

• Chesley Testifies In Fen-Phen Case
  (Louisville Courier-Journal) -- While Chesley was on the witness stand, defense lawyers played excerpts of a 2006 deposition in which Chesley supported a key contention of defendants William Gallion, Melbourne Mills Jr. and Shirley Cunningham Jr., who are charged with defrauding clients out of $65 million from the $200 million settlement of the diet-drug case in 2001.
  

• Postexercise Evaluation Of Pulmonary Artery Pressure
  (Medscape) -- Is there any validity to postexercise evaluation of pulmonary artery pressure?
  

• Judge, Lawyer Clash At Fen-Phen Trial
  (Louisville Courier-Journal) -- "We were like an insurance company where the hurricane didn't strike, so we got to keep the premium," the suspended Lexington lawyer testified in his diet-drug fraud trial in U.S. District Court.
  

• Serum Sodium Predicts Mortality Ten Times Higher In PAH Patient
  (Newswise) -- Patients with pulmonary arterial hypertension (PAH)-chronically high blood pressure in the blood vessels of the lungs-whose serum sodium levels are low (called hyponatremia, or HN) have a very poor chance of survival and a high rate of right-heart failure (RHF), according to new research from the University of Pennsylvania.
  

•   All Of Us Have The Ability To Give The Ultimate Gift
  (redOrbit) -- Addressing a conference in Edinburgh this week, Scottish Health Secretary Nicola Sturgeon, who previously seemed quite enthusiastic about "presumed consent" for organ donation, appeared to back away from it. Instead, she opted to stress what she thought could be done to tackle the issue without changing the law, seemingly on the basis that the public isn't ready for such a change.
  

• Fen-Phen Evidence Missing
  (Cincinnati Enquirer) -- When U.S. Assistant Attorney E.J. Walburn pressed Gallion on his claim that files were missing, the defendant said either the government was withholding evidence or a former paralegal - unindicted co-conspirator Rebecca Phipps - illegally removed files before federal agents confiscated everything.
  

• Addressing Cardiology Concerns In PAH Care
  (Medscape) -- This CME activity is based on transcripts and slides of presentations as delivered by the faculty at the "Addressing Cardiology Concerns in Pulmonary Arterial Hypertension (PAH) Care" symposium held in Chicago, Illinois, on March 31, 2008.
  

• Sleep Apnea Linked To Memory Loss
  (Washington Post) -- People with sleep apnea show tissue loss in brain regions that help store memory, a University of California, Los Angeles (UCLA) study shows.
  

• Lupus More Severe In Patients With Southern European Ancestry
  (EurekAlert) -- According to the results of the research, northern European ancestry is shown to be associated with the relatively milder mucocutaneous (skin) manifestations of SLE, whereas southern European ancestry contributes to more severe manifestations of the disorder such as nephritis (inflammation of the kidneys) and increased production of specific autoantibodies (antibodies that fail to recognise and therefore attack the body's own cells, tissues or organs).
  

• Fen-Phen Maker's Testimony Disputed
  (Lexington Herald-Leader) -- A lawyer accused of taking millions of dollars that should have gone to plaintiffs in a class-action settlement testified Wednesday that he thought his clients received more money than most people who sued American Home Products, maker of the diet drug fen-phen.
  

• PAH And Cardiovascular Mortality In Patients With Rheumatoid Arthritis
  (Medscape) -- Does pulmonary arterial hypertension have an intermediary role in cardiovascular mortality in patients with rheumatoid arthritis?
  

• Witness In Fen-Phen Case Says Rules Required Secrecy
  (Lexington Herald-Leader) -- Three lawyers accused of taking more than $65 million from their former clients could not give their clients details about a 2001 diet drug settlement because it would have violated a confidentiality clause, an expert in class-action litigation testified Monday.
  

• Cancer Drug Velcade Might Work In Lupus: Study
  (Reuters) -- The injected medicine is currently given to patients with multiple myeloma, a cancer of the white blood cells. But tests on mice suggest it may also fight systemic lupus erythematosus, the research team reported in the journal Nature Medicine.
  

• Doctors Urged To Look For Link Between Type 2 Diabetes, Sleep Apnea
  (HealthDay News) -- The ties being found between type 2 diabetes and obstructive sleep apnea (OSA) indicate these disorders have major implications on public health, the International Diabetes Federation warns.
  

• Fen-Phen Lawyer Testifies
  (Lexington Herald-Leader) -- William Gallion admitted Friday that he never told a judge in a controversial $200 million fen-phen settlement that he had contracts with his clients that would limit his fees to roughly 30 percent of the settlement.

• Viagra Trial For Sickle Cell Dad
  (Willesden and Brent Times) -- The trial will look into the effects of sildenafil - known as Viagra - on the relationship between pulmonary hypertension, an extreme facet of the disease which affects the heart, and sickle cell.
  

• Deficiency Of The NHE1 Gene Prevents Hypoxia-Induced PH And Vascular Remodeling
  (redOrbit) -- Objectives: To determine the causal role of the NHE1 gene in pulmonary hypertension and vascular remodeling.
  

• Circulating Endothelial Microparticle Levels Predict Hemodynamic Severity Of PH
  (redOrbit) -- Objectives: We tested the hypothesis that circulating MPs are increased in patients with PH and that identifiable subgroups of MPs predict the hemodynamic severity of this condition progression.
  

• NKU Law Professor Testifies At Fen-Phen Trial
  (Lexington Herald-Leader) -- Edward Brewer III, a professor at Northern Kentucky University Salmon P. Chase College of Law, testified Tuesday and Wednesday in federal court in Covington that Shirley Cunningham Jr., Melbourne Mills and William Gallion violated Kentucky rules of civil procedure and ethics rules for lawyers when they failed to tell 440 clients who took the diet drug fen-phen that they had settled their 2001 lawsuit.
  

• German Merck KGaA Starts Mid-Stage Lupus Trial
  (Reuters) -- "Atacicept has the potential to alter the course of SLE, a complex and devastating disease," said Anton Hoos, Merck Serono's head of global development, in a statement.
  

• Low-Salt Diet May Not Be Best For Heart
  (HealthDay News) -- Surprising new research suggests that a diet low in salt may be worse for your heart than eating lots of salt, but don't start eating potato chips just yet.
  

• Collapsible Valve Allows Less-Invasive Heart Surgery
  (Chicago Tribune) -- The valve can be folded to about the width of a pencil, attached to a catheter and inserted into a patient's body, a procedure akin to a balloon angiography, which forces open narrowed blood vessels. The device is inserted in the heart, where it unfolds to replace a diseased valve, which is then pushed aside.
  

• New Approach To Treating Autoimmune Disease Developed
  (Science Daily) -- Weizmann Institute scientists have developed a method that in the future may make it possible to treat autoimmune diseases effectively without necessarily knowing their exact cause. Their approach is equivalent to sending a police force to suppress a riot without seeking out the individuals who instigated the unrest.
  

• Gilead And Navitas Announce Agreement For Cicletanine For The Treatment Of PAH
  (Gilead) -- Gilead plans to evaluate cicletanine for the treatment of PAH in a Phase II study which is expected to commence prior to the end of 2008.
  

• Spotlight: New Lease On Life, Thanks To Donors
  (The New Straits Times) -- Transplants at the National Heart Institute (IJN) in Malaysia.
  

• Measuring Blood Clotting Time – At Home
  (medinews.com) -- The home self-testing service solution helps simplify coumadin and warfarin drug management for patients along with a faster turnaround of test results for the physician, who suffers no delays in receiving the data necessary to manage the patient, and without an additional investment layout for the practice.
  

• Why It's Hard To Maintain Weight Loss
  (LA Times) -- Most people can lose weight. But few can maintain their new weight for long. Researchers are now tackling that problem, and what they're learning is disconcerting. The human body, it seems, is designed to sabotage weight loss at every turn -- once a body has been fatter, it wants to get back to the weight that it used to be.
  

• Witness Says She Was Told To Destroy Fen-Phen Documents
  (Louisville Courier-Journal) -- One of the three lawyers charged with plundering Kentucky’s $200 million fen-phen settlement told a legal assistant to destroy documents showing how the clients were paid, according to the aide’s testimony today.
  

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