April 30, 2007

• Committee For Medicinal Products For Human Use Summary Of Positive Opinion For Soliris
  (PharmaLive) -- the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Soliris (eculizumab), 300 mg, concentrate for solution for infusion intended for treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis. Soliris was designated as an orphan medicinal product on 17 October 2003.
  

• Baby Ella: 'The Little Miracle'
  (KSDK) -- Thursday, the infant called one of the sickest babies ever treated at SSM Cardinal Glennon Children's Medical Center got her last tube removed and will soon go home.
  

• Blood Test Could Reduce Biopsies And Immunosuppressive Therapy In Heart Transplant Patients And Detect Organ Rejection In Lung Transplants
  (Medical News Today) -- XDx, a molecular diagnostics company, has announced that its AlloMap® molecular expression test will be the subject of presentations and discussions at the 27th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) at the Hilton San Francisco.
  

• Increasing Survival Of Organ Transplant Patients By Reducing Time Interval For Transported Organs
  (Medical News Today) -- Preservation of an organ intended for transplant during transport from donor to recipient is of primary concern in ensuring a successful transplant. Research presented at the ISHLT 27th Annual Meeting and Scientific Sessions today explores two diverging systems for pump preservation -- the Organ Care System (OCS) and the cold preservation method, and how they each effect survival for heart transplant patients.
  

• How Businessman Beat Rare Disease
  (This Is Lancashire) -- Ray, husband to Chrissy, 59, said: "The doctor told me there were small clots, medium clots and big clots. He said Frankly yours is a massive clot and we shouldn't be having this conversation.' "I was told at the end of my diagnosis that I had one to two years to live without any form of medication but because of the way the clot was in my lung it was possible for me to have the operation."
  

• Patients Struggle Under Medicare's Wait
  (The Dallas Morning News) -- Like 1.5 million other Americans with severe disabilities, he has to wait two years to get help from Medicare for doctor visits, hospital stays and medications.
  

• ISHLT Membership Explores Expansion Of Computer Modeling System For Organ Allocation To The International Transplant Community
  (PRNewswire) -- The International Society for Heart and Lung Transplantation (ISHLT) announces evaluation of a new mathematical modeling system for lung allocation in the United States and the ethical issues surrounding organ allocation facing patients awaiting transplants. Both will be discussed at its 27th Annual Meeting and Scientific Sessions, today in Satellite Symposium 9, Continued Evaluation of Heart and Lung Allocation Using Evidence Based Research.
  

• Changing Heart Transplant Drugs Could Boost Kidney Function
  (Washington Post) -- Changing a heart transplant patient's immunosuppression drug regimen may improve their kidney function and help prevent coronary artery disease, according to two Mayo Clinic studies.
  

• Fen-Phen Suit Heads To Mediation
  (Cincinnati Post) -- The attorney for hundreds of people who say lawyers representing them in a suit against the diet drug fen-phen defrauded them will try to settle their differences in mediation sessions next month.
  

• Are 100-Calorie Packs Healthy?
  (WebMD) -- Consumers are turning to 100-calorie snack packs -- of crackers, cookies, chips, and more -- in record numbers. Obviously, many see these convenient little bags as a great way to control calories and keep them from polishing off whole bags of less-than-healthy snacks.
  

• New Strategies For PAH: Evaluation And Management
  (Medscape) -- The availability of newer drugs for pulmonary arterial hypertension (PAH) has radically changed its management and significantly improved both quality of life and mortality for patients, according to a review published in the April issue of the Southern Medical Journal. This review highlights the presentation of PAH, the diagnostic approach, and treatment options.
  

• Teen Makes Film About Her Life-Threatening Condition
  (Gazette & Herald) -- Lyneham teenager Stacie Pridden is juggling her GCSE revision this week in order to raise awareness of the potentially fatal disease she has lived with since birth.
  

• Scottsdale Woman Gets Valley's First Lung Transplant
  (KPHO) -- "I think it's high time that we have a lung-transplant program here, and we're very excited," said Dr. Ross Bremner, surgical director of the hospital's Center for Thoracic Disease. "There's an extensive amount of surgery involved ... but the operation went very smoothly."
  

• Cellerant Therapeutics Reversed Autoimmune Disease in Lupus Mice
  (Business Wire) -- Cellerant Therapeutics today announced the publication of data suggesting that established autoimmune disease can be reversed or stabilized by the transplantation of purified allogeneic (donated) hematopoietic (blood forming) stem cells (HSC) in a mouse study of Systemic Lupus Erythematosus (SLE).
  

• ResMed Recalls Sleep Apnea Devices
  (The Age) -- Australian medical equipment manufacturer ResMed has announced a worldwide voluntary recall of about 300,000 S8 flow generators used for the treatment of obstructive sleep apnea. Resmed's recall notice (pdf)
  

• Weight-Loss Drugs: Hoopla And Hype
  (New York Times) -- More than $1.3 billion a year is spent on dietary supplements for weight loss, most of which have had little or no scientifically acceptable testing for effectiveness and safety, especially when used for months. More than 20 percent of women and nearly 10 percent of men have used nonprescription weight-loss supplements, the Centers for Disease Control and Prevention says.
  

• Viagra Has Given Me Chance To Stay Alive
  (Scotsman) -- Inside his spotless Corstorphine bungalow, 54-year-old Grant Crow answers the phone with a gentle voice as another call comes through from a worried patient who has just been diagnosed with the same life-threatening illness he has - pulmonary hypertension (PH).
  

• A Second Chance At Life: Many Lives Are Saved By Organ Donors
  (Farmington Daily Times) -- When she was 24, Joe was diagnosed with primary pulmonary hypertension, which is a result of high blood pressure in the arteries that supply blood to the lungs. Joe spent the next four years undergoing treatment through her physician.
  

• Port Charlotte Woman Gets Lung Transplant
  (Charlotte Sun-Herald) -- Pat Frey Miller, diagnosed with scleroderma, needed a double lung transplant. After months of waiting, last fall she received one new lung. She is now back home.
  

• Verto Begins Phase I/II Trial Of Lupus Drug
  (Globes) -- Hadasit Bio CEO Ophir Shahaf said this was a combined Phase I/II trial that simultaneously included a safety test on a small number of patients to ensure that there were no side effects, and an effectiveness test to examine whether there was a drop in Lupus antibodies.
  

• Fitness Program Produces Results For Chair-Bound Population
  (PRWeb) -- Renee Wiggins' new health & fitness book "Can I Exercise Sitting Down?" offers a unique workout program designed for individuals that are chair bound due to physical challenge or desk occupation.
  
  Available at Amazon

• Feeling The Chill: Raynaud's Phenomenon Sufferers Battle Cold Hands, Feet - And Misconceptions
  (Eagle Tribune) -- The New York-based Raynaud's Association, an international support group of about 2,500 patients, estimates that 5 percent to 10 percent of Americans experience the phenomenon, though many may not know they have it.
  

• Cuba To Carry Out First Double Lung Transplant
  (Prensa Latina) -- Cuba is to carry out the first double lung transplant in the last quarter of this year, announced Dr. Manuel Sarduy Paneque, Head of Bronchoscopy Department at the Pneumonology Institute.
  

• Diffusion Capacity, Pulmonary Hypertension, And Idiopathic Pulmonary Fibrosis
  (Medscape) -- Idiopathic pulmonary fibrosis (IPF) can be complicated by the development of pulmonary hypertension (PH). The combination of the two has been shown to portend a worse prognosis. A reduced diffusion capacity (DLco) has also been shown both to be associated with a worse prognosis in patients with IPF and to have a relationship with coexistent PH. The investigators in this study sought to examine the relationship between PH, DLco, and outcomes in a cohort of patients with IPF.
  

• Endothelial Progenitor Cell Transplant Helpful In Pulmonary Hypertension
  (Medscape/Reuters) -- Intravenous infusion of autologous EPCs appears to be feasible and safe," senior investigate Dr. Jun-Zhu Chen told Reuters Health, "and may beneficially affect exercise capacity and pulmonary hemodynamics in patients with idiopathic PAH."
  

• Sterility Worries Lead To Massive Seizure Of Implantable Medical Devices
  (San Diego Union-Tribune) -- Patients who think they may have received a Shelhigh device during surgery should contact their doctors for more information, the FDA added.
  

• Atrial Septostomy Improves Right Heart Failure In Pulmonary Hypertension
  (Medscape/Reuters) -- Creating a right-to-left shunt at the atrial level by balloon septostomy improves measures of right heart failure in patients with pulmonary hypertension (PH), according to a report in the April issue of Chest.
  

• Fen-Phen Lawyer Fights Accusations Of Wrongdoing
  (Law.com) -- Prominent personal injury attorney Stanley M. Chesley of Waite, Schneider, Bayless & Chesley in Cincinnati has threatened to seek sanctions against plaintiffs counsel for allegedly falsely accusing him in court pleadings of conspiring with three Kentucky lawyers to misappropriate $126 million of a $200 million Kentucky fen-phen settlement.
  

• Encysive Pharmaceuticals Announces Launch Of THELIN In The Netherlands
  (Encysive) -- Encysive Pharmaceuticals today announced the commercial availability of THELIN(r) (sitaxentan sodium) 100 mg tablets in the Netherlands for the treatment of pulmonary arterial hypertension (PAH).
  

• Bloodstream Infections Among Patients Treated With Intravenous Epoprostenol Or Intravenous Treprostinil For PAH
  (Medscape) -- CDC conducted a retrospective investigation with the assistance of several state health departments and the cooperation of seven PAH treatment centers to determine the relative rates of BSI in a sample of patients treated with IV treprostinil and IV epoprostenol during 2003-2006.
  

• Lung Transplantation, Primary Graft Dysfunction, And Bronchiolitis Obliterans Syndrome
  (Medscape) -- The authors of this article sought to investigate the relationship of these 2 distinct entities, by examining whether PGD, occurring immediately post-transplant, predisposes patients to the subsequent development of BOS.
  

• $1 Billion Fen-Phen Case Settles Before Appellate Oral Arguments
  (Law.com) -- Lawyers representing Wyeth and the plaintiffs in Jerry Coffey, et al. v. Wyeth, et al. have negotiated a settlement in the suit.
  

•   Organ Bill Clears Hurdle
  (York Region Era Banner) -- If passed, Bill 67 will make it mandatory for Ontario residents 16 and over to answer an organ donation question. People would answer the question while renewing or applying for a driver's licence or health card.
  

•   Double-Lung Transplant Teen Celebrates Birthday
  (The Australian) -- Recalling the frightening two months before her operation to correct a rare disorder known as primary pulmonary hypertension, she said: "I was on an oxygen mask for the last months. I couldn't do most things. I couldn't shower by myself. I couldn't walk more than 10m. I was pretty much bed-ridden.
  

• Sleep Disorder Linked To Heart Failure Patient Deaths
  (Newswise) -- The study followed 164 patients with heart failure for more than seven years, and found that those with obstructive sleep apnea (OSA) had double the death rate of those patients who did not have sleep apnea. Of the 37 patients with untreated OSA, the death rate was 24% in contrast to 12% for the 113 patients with no sleep apnea.
  

• Lupus: New Insights, New Drugs
  (Newsday) -- Today, the majority of lupus patients do not die from it, but many live with damaged organs, blood clots, brain problems and joint inflammation. And for the first time in decades, a new wave of drugs designed for lupus patients is on the horizon, with a dozen or so medicines in different stages of experimental testing.
  

• How Much Does It Cost To Lose 30 Pounds?
  (Bankrate.com) -- Despite studies saying North Americans are getting fatter every year, people are obsessed with weight loss, and the business of losing weight has ballooned into a $46.3 billion industry. How much would you be willing to spend to lose 30 pounds?
  

• Sounding The Alarm About Sleep Apnea
  (News In Health) -- If you were at the doctor’s office and suddenly stopped breathing for 20 seconds, they’d call an ambulance. During sleep, the more than 12 million Americans estimated to have obstructive sleep apnea may stop breathing 10 or more times an hour.
  

• Educator In Need Of Community’s Support
  (Laurel Leader Call) -- In June 2006, soon after developing pneumonia, Walker was diagnosed with idiopathic pulmonary fibrosis, a rare lung disease.
  

• New Book Release By Barbara De Witt Portrait Of Success -- Lupus Patients Who Celebrate Life
  (eMediaWire) -- Portraits of Success, published by Lupus International in collaboration with Angel City Press, is a book that showcases the lives of people that celebrate life everyday despite the fact that they have lupus. The brave people in this book share their challenges and advice to others that suffer from this devastating disease. Their encouraging words demonstrate the hope and faith that someday, there will be a cure.
  

• New Urgency In Debating Health Care
  (New York Times) -- With their medical costs ballooning, top executives of large companies are starting to speak up again — and many are calling for a national approach to fixing health care.
  For more information, or to contact your elected officials about this, see Action Central

• Garlic May Ward Off...A Lung Condition
  (PakTribune) -- The garlic ingredient, called allicin, seems to ward off pulmonary hypertension, or high blood pressure in the arteries that bring blood to the lungs.
  

• Fen-Phen Plaintiffs To Get Award
  (Lexington Herald-Leader) -- Special Judge William Wehr said in an order Wednesday that he intended to award the plaintiffs something, but said more information had to be gathered before a decision could be made.
  

• Benefits With Risks — Bush's Tax-Based Health Care Proposals
  (New England Journal of Medicine) -- In his State of the Union address in January, President George W. Bush announced a major two-part health initiative that would create a new uniform tax deduction for all those obtaining health insurance and provide assistance to states that make basic private health insurance available to residents.
  
  For more information, or to contact your elected officials about this, see Action Central

• Chesley Made Too Much On Fen-Phen Settlement
  (Cincinnati Enquirer) -- "Chesley was paid more than he should have been and, therefore, will ultimately be responsible for some repayment," Senior Judge William Wehr wrote in an order filed Wednesday in Boone Circuit Court.
  

• Older Donors And Lung Transplantation
  (Medscape) -- Since there is an ongoing donor shortage, all criteria that constitute an "acceptable" donor have been more closely scrutinized. Transplant centers, especially those with more experience and greater volumes, continue to "push the envelope" with extended-criteria donors. The term "marginal" donor is no longer used because it is not regarded as "PC" (patient-considerate).
  

• FDA Approves Alexion's Soliris(TM) For All Patients With PNH
  (DrugNewswire) -- Alexion Pharmaceuticals, Inc., announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Soliris(TM) (eculizumab). Soliris is the first therapy approved for paroxysmal nocturnal hemoglobinuria (PNH), a rare, disabling and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris is indicated for the treatment of patients with PNH to reduce hemolysis.
  

• States Revising Organ-Donation Law
  (Washington Post) -- State legislatures are rewriting legislation governing organ donations in one of the most ambitious initiatives in at least 20 years to alleviate the chronic shortage of kidneys, livers and other body parts, an effort that some doctors and ethicists fear tilts too far toward allowing organs to be taken.
  

• RSVP Measurements And Pulmonary Arterial Hypertension
  (Medscape) -- How do you define pulmonary arterial hypertension (PAH) with the right ventricular systolic pressure (RVSP) measurement by echocardiography?
  

• Genelabs Technologies Receives Agreement From FDA On Special Protocol Assessment For Phase III Trial Of Prestara In Lupus
  (PharmaLive) -- The primary endpoint for this randomized, double-blind, placebo-controlled phase III clinical trial will be time to first severe flare based on the SELENA SLEDAI composite definition of severe lupus flare. The principal secondary endpoint will be time to first treatment intervention for moderate or severe lupus flare.
  

• The Future Of Universal Health Care
  (Forbes) -- For years the unholy grail, from a political standpoint, has been "universal health care." While giving everyone access to regular medical care is a nice thought, figuring out how to pay for all that care--without jacking taxes through the roof--is a policy nightmare.
  
  For more information, or to contact your elected officials about this, see Action Central

• A Patient’s Demands Versus A Doctor’s Convictions
  (New York Times) -- Doctors talk all the time about a patient’s right to refuse treatment. But what about the right to demand it?
  

• Encysive Pharmaceuticals Announces Launch Of Thelin In Republic Of Ireland
  (Encysive) -- Encysive Pharmaceuticals today announced the commercial availability of THELIN(r)(sitaxentan sodium) 100 mg tablets in the Republic of Ireland for the treatment of pulmonary arterial hypertension.
  

• Gene Behind Autoimmune Diseases Identified By Researchers
  (Medical News Today) -- A report in the March 22 issue of the New England Journal of Medicine reveals that a pinpointed region of chromosome 17, a gene named NALP1, could be a new target of treatment for autoimmune diseases. This is a particularly exciting discovery because NALP1, a gene known to control part of the immune system that serves to alert the body to viral and bacterial attacks, has not previously been specifically implicated in autoimmune diseases.
  

• Medicare Says University Of Utah Needs More Lung Transplants
  (The Salt Lake Tribune) -- UNOS has the authority to revoke a program's certification as a transplant center, and Medicare could withdraw its approval. Neither move is likely, said Kim Phillips, a registered nurse and the U. program's administrator.
  

• Heart Valve Grown From Stem Cells
  (BBC) -- Heart surgeon Sir Magdi Yacoub, who led the team, said doctors could be using artificially grown heart components in transplants within three years.
  

• Unapproved Drugs Spark Life-And-Death Debate
  (USA Today) -- Every day, patients with life-threatening illnesses run out of FDA-approved treatments. In desperation, some seek drugs that have not yet been approved by the agency and, in some cases, have not even been widely tested. These patients argue they have nothing to lose and are willing to risk taking even a little-studied drug that offers a glimmer of hope.
  

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