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Contents
Chronic
Diseases in America
Generic Companies Don’t Face These Problems Advertising Controls Google Health RNA Interference (RNAi) StarClose® SE Vascular Closure System Nipple Cream Warning Cost of ADHD Pfizer Patent Upheld Inequitable Conduct Ranbaxy and Merck Indian Generic Drug Makers Chronic Diseases in America For the first time, it appears that more than half of all insured Americans are taking prescription medicines regularly for chronic health problems, a study shows. The most widely used drugs are those to lower high blood pressure and cholesterol -- problems often linked to heart disease, obesity and diabetes. The numbers were gathered last year by Medco Health Solutions Inc., which manages prescription benefits for about one in five Americans. Experts say the data reflect not just worsening public health but better medicines for chronic conditions and more aggressive treatment by doctors. For example, more people are now taking blood pressure and cholesterol-lowering medicines because they need them. In addition, there is the pharmaceutical industry's relentless advertising. Generic Companies Don’t Face These Problems Hundreds of patients taking Pfizer Inc's anti-smoking drug Chantix have reported serious accidents, vision problems and heart trouble, researchers said, sending shares of the world's largest drugmaker to their lowest level since 1997. U.S. aviation regulators responded quickly to the research, saying they would prohibit use of the drug by private and commercial pilots. Chantix, also known as varenicline, has already been linked to depression and suicide, among other problems. Researchers at the nonprofit Institute for Safe Medication Practices, and Wake Forest University, said they found hundreds of reported problems since the drug's 2006 approval that included blurred vision, dizziness, confusion and loss of consciousness, which were already mentioned on the drug's label. Advertising Controls In a letter to the chief executives of Merck & Co Inc, Pfizer Inc, Johnson & Johnson and Schering-Plough Corp, Reps. John Dingell and Bart Stupak asked the companies to refrain from marketing products to consumers until certain studies are completed. The Democratic lawmakers also called on several drug companies to voluntarily curb advertisements targeting consumers, including withholding any ads for new products for two years. The Michigan Democrats are investigating whether companies are misleading potential patients through television commercials and other direct-to-consumer advertisements. The letters come less than two weeks after the committee's health panel questioned lower executives from the drugmakers about aggressive marketing tactics for two cholesterol drugs -- Pfizer's Lipitor and Merck and Schering-Plough's Vytorin joint venture. The committee also probed ads for Johnson & Johnson's anemia drug Procrit. Google Health Google Inc unveiled Google Health, U.S. health information service that combines the leading Web company's classic search services with a user's personal health records online. The password-protected service, which can be found at www.google.com/health/, stores a user's basic medical history and gathers relevant information connected to their health conditions. The service includes links to major U.S. pharmacies, doctors' groups and medical testing labs. Partners include Walgreen Co, Longs Drugs Stores Corp, CVS Caremark Group, AllScripts, Quest Diagnostics and the Cleveland Clinic. The company had previously said it was working with health insurers such as Aetna Inc and Wal-Mart Stores Inc pharmacies. RNA Interference (RNAi) RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. RNAi therapeutics target the cause of diseases by potently silencing specific messenger RNAs (mRNAs), thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way. StarClose® SE Vascular Closure System Abbott announced the launch of the StarClose® SE Vascular Closure System, a next-generation vessel closure device engineered to enable fast, safe and secure closure of the femoral artery access site following a catheterization procedure. StarClose SE is available in the United States and Europe. StarClose SE, which stands for "Safe and Extravascular," builds upon the premium design of its predecessor, StarClose, with more ergonomically-friendly design features. StarClose SE advancements include: Improved ease of use, with an intuitive, numbered system, providing visual guidance and audible "clicks" for each step leading to clip deployment Immediate vessel closure with deployment of a shape-memory clip onto the surface of an artery, allowing patients to recover and be discharged sooner than with manual compression Added device stability for the operator during clip deployment. StarClose SE utilizes the same nitinol (nickel and titanium) clip technology as StarClose to close the femoral artery access site after a catheterization procedure. When deployed, the small nitinol clip grasps the tissue on top of the artery around the access site in a purse-string fashion and closes the opening in the femoral artery rapidly and securely with minimal affect to the lumen diameter or the blood flow inside the vessel. Catheterization is a procedure commonly used to evaluate or treat certain types of disease in vessels of the heart and other parts of the body. The procedure involves the insertion of a flexible tube, called a catheter, into the femoral artery in the leg. The physician will use the catheter to observe the condition of the coronary or peripheral blood vessels or to treat blockages in the vessels. Following the procedure, the physician will remove the catheter and close the femoral artery access site. Over the years, a variety of methods, such as direct pressure (manual compression), sandbags and mechanical clamps, have been used to close the puncture site and achieve hemostasis (cessation of bleeding). Many of these methods have proved less than satisfactory, causing patients significant discomfort and requiring up to several hours of bedrest. Nipple Cream Warning The Food and Drug Administration warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif. The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said. The potentially harmful ingredients in the cream are chlorphenesin and phenoxyethanol. The company has stopped selling the cream. The FDA said consumers should stop using the cream and consult a doctor if they experience problems or believe that their infant may have experienced problems due to the product. Mothers whose children may have suffered adverse effects because if this product should contact the FDA's MedWatch at 800-332-1088. Cost of ADHD Attention-deficit hyperactivity disorder (ADHD) can lead to a loss of a month's worth of work every year for adults with the condition. A Harvard study published in the online edition of Occupational and Environmental Medicine suggests that employers screen workers for ADHD and offer treatment. The study found that the losses for adults with ADHD were mostly in terms of quantity and quality of work, rather than missing days of work. In the study, researchers interviewed more than 7,000 workers aged 18 to 44 in 10 countries. They found that about 3.5% of the workers had ADHD. The rates of ADHD and lost performance days varied by country, with the U.S. rate at 4.5%, at a cost of 28.3 days performance on average. Pfizer Patent Upheld Pfizer Inc said that the Australian Full Federal Court in Victoria has upheld on appeal the exclusivity of its basic patent covering atorvastatin, the active ingredient in Lipitor. The ruling, the culmination of a lawsuit filed in 2005 by generic drug manufacturer Ranbaxy, preserves Lipitor’s patent coverage in Australia through May 2012. Ranbaxy can appeal the decision. The court found that a proposed Ranbaxy generic product would infringe Pfizer’s basic Lipitor patent (AU 601,981). A second patent covering the calcium salt of atorvastatin (AU 628,198), which expires in September 2012, was ruled invalid by the court. Pfizer has the opportunity to appeal that ruling. The Australian decision will not impact ongoing Lipitor patent actions in other countries, including the United States. Pfizer said it would continue to vigorously defend against challenges to its intellectual property, noting that patents provide the necessary incentive to invest in new and life-saving medicines that benefit millions of patients globally. Intellectual property protection, especially short-term patent protection, is essential for the survival of innovative biopharmaceutical industry and to develop new drugs seeking answers to some of the world's most urgent medical needs, which involves about 15 years of research by hard working scientists, and billions of dollars of investment. Inequitable Conduct The CAFC affirmed a ruling that the Lovenox patents owned by Aventis were unenforceable due to a failure to submit important experimental information during prosecution with an intent to deceive USPTO. The Lovenox patents are directed toward a heparin based drug used to help prevent blood clots. The specification includes a particular set of experimental examples that show an increased half-life of the claimed admixture. During prosecution, the applicant used those examples along with additional data to prove that its drug was inherently different from a prior art drug. Aventis did not report to the PTO that its experiments showing an increased half-life of the claimed admixture used a different dosage than those testing the prior art drug. Half-life of a compound does not necessarily depend on its amount, but the amount and number of times required per day by patient changes based on the half life of the drug. Judge Rader dissented arguing that there was also compelling evidence that Aventis did not intend to deceive the patent examiner. Ranbaxy and Merck India's Ranbaxy signed a five-year pact with Merck to develop new anti-infectives. Ranbaxy, which received an undisclosed upfront payment, says it stands to earn more than $100 million from each new therapy developed in the five-year collaboration, which follows a similar deal it signed with GlaxoSmithKline. Ranbaxy researchers will advance therapies into Phase II, at which point Merck will take over the development program. Ranbaxy shares jumped more than five percent on the news. This new deal signals an ongoing effort by big pharma companies to reduce their expenses by shifting development programs into China and India. Eli Lilly has also aggressively pursued an Asian strategy for its R&D work as well. Indian Generic Drug Makers Indian drugmaker Ranbaxy Laboratories Ltd has received approval from the U.S. Food and Drug Administration for muscle relaxant cyclobenzapine hydrochloride tablets. The FDA has also granted tentative approval to Lupin Pharmaceuticals Inc, a unit of Lupin Ltd, for ramipril capsules, used in treating cardiovascular disease and high blood pressure. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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