New Finger Joint "Grown" In The LaboratoryYou've seen the news photos of the genetically engineered ear on the back of a mouse. Now a research team has "grown" a finger joint complete with bone, cartilage and tendon. This tissue engineering is a beginning that could lead to "growing" replacement limbs of all types for humans. In a report in the Journal of Bone and Joint Disease, the scientists at the Northeastern Ohio University College of Medicine described the process they used to make the joint. They created a polymer frame they call a "scaffold" in the shape of a human finger and put separate bone, tendon and cartilage scaffolds in the back of a mouse. The researchers "seeded" the scaffolds with flesh from a calf and other calf cells. The calf tissue and cells developed and grew into the various scaffolds, using blood supplied by the calf. The porous, biodegradable scaffolds were absorbed into the new tissue. The combination of bone, cartilage and tendon grew together into a humanlike finger joint in forty weeks. William Landis, one of the scientists on the project said, "We were actually surprised by what we found. This work could eventually mean we would be able to grow new limbs for paraplegics and amputees, or for people whose bones were destroyed by disease." It will take many years to actually create limbs that people could use. Some of the major problems are the formidable opposition put up by the body's immune system and learning how to stimulate growth in the body's nerves. Some of the team members, including Noritaka Isogai, who is based in Osaka, Japan, and Joseph Vacanti, a pediatric surgeon at Boston's Massachusetts General Hospital, plan to continue to collaborate with Landis. Landis is re-establishing the project in a new lab at the medical school where he hopes to learn how the joint grew. The medical school has targeted skeletal bioengineering as a key focus for research and hopes to become comparable with sites in Boston and California that are the current centers for tissue engineering.
New Long-Acting Insulin Glargine Submitted For ApprovalHoechst Marion Roussel announced it has submitted the insulin glargine, a long- acting, once-daily basal insulin, for the approval of both the US Food and Drug Administration (FDA) and the European Medicinal Evaluations Agency (EMEA). The action of glargine imitates the human physiological basal insulin secretion. It differs from human insulin in three amino acids. This changes the physical properties of the biosynthetic insulin and slows its release from the subcutaneous tissue into the circulation. The slower release means that once a day use in people with Type 1 or Type 2 diabetes provides continuous insulin delivery throughout the day and night. It's duration of activity nor variation in day-to-day activity were not released. Type 1 and 2 diabetes affect more than 142 million people around the globe and the World Health Organization estimates diabetes will double by the year 2025.
New Diet Drug Xenical Blocks Fat DigestionNo longer does a person wanting a drug to help with weight loss need to use an appetite suppressant. Now the Food and Drug Administration has approved an anti-obesity drug that works by blocking the body's absorption of almost one third of the fat that is eaten, as opposed to blunting hunger. The drug, orlistat, developed by Hoffman-LaRoche of Nutley N.J., was approved for seriously overweight people who meet the definition of obese: 30 percent overweight or who are less overweight but who are at risk of another disease, for example people who are 20 percent overweight and have high blood pressure, high cholesterol or diabetes, conditions that often improve with weight loss. At 5 feet 5 inches tall, a person would weigh 180 pounds and 160 pounds, respectively, to fit those criteria. But doctors will be able to prescribe orlistat, marketed as Xenical, for anyone, although it has fewer side effects when taken by someone on a low-fat diet. The demand will likely be high for this weight control product but it will not be cheap: the drug is recommended for use three times a day, for periods of a year or longer at a charge of $1.10 per capsule. It is hard to overestimate the interest of Americans in losing weight, said Dr. David F. Williamson of the Centers for Disease Control and Prevention, an epidemiologist who studies diabetes and who has written about the drug. He expects drug sales to be brisk. Experts were quick to say that orlistat has drawbacks. First, it helped obese people lose only small amounts of weight. In one year of taking the drug in clinical trials, most patients experienced weight loss ranging from 5 percent to 10 percent of their initial body weight, the company said. And that was in combination with a reduced calorie diet. Other drawbacks are in the way orlistat works in the gastrointestinal tract, blocking an enzyme that is needed to digest fat. Instead of being digested, a third of the fat a person eats will accumulate in the intestines and be excreted in the stool. The fat in the intestine can cause unpleasant side effects, like bloating, flatulence, oily stool, diarrhea and fecal incontinence, that tend to discourage patients from eating fatty foods. Also by blocking fat absorption, the drug also blocks absorption of the fat-soluble vitamins A, D, E and K, as well as beta-carotene, and so patients must take daily vitamin supplements.
SmithKline Arranges Help To Sell New Drug AvandiaHow can you insure that a new product is marketed successfully? All the traditional strategies come to mind, but sometimes you take it a step further. SmithKline Beecham is doing just that by recruiting the sales force of a rival pharmaceutical company to promote its new product. SmithKline has announced an agreement with Bristol-Myers Squibb to promote their new drug, Avandia, which has been approved by a key FDA advisory committee and is expected to win final approval in June. When approved, Avandia will be prescribed singly and as a combination drug with Bristol-Myers' top-selling diabetes drug, Glucophage. SmithKline is hoping to use the connections Bristol-Myers has built over the years marketing Glucophage. And Bristol-Myers is hoping to retain its share in the diabetes drug market after its patent on Glucophage expires in three years. Analysts expect that Avandia could quickly reach sales as high as $1 billion. It projects treating diabetes with fewer risk to the liver than Warner-Lambert's Rezulin, a drug that had new warning labels added by the FDA last month because of patients suffering liver failure. Food and Drug Administration officials say 43 Rezulin patients have suffered acute liver failure with seven liver transplantations and 28 deaths. Approximately 15 million people have Type 2 or adult-onset diabetes in the United States. Most patients take a single pill or a combination of pills. An important question is how will sales representatives recommend doctors use these drugs. SmithKline President J.P. Garnier said he expects Bristol-Myers sales representatives to recommend that doctors prescribe Avandia for new diabetes patients and in combination with Glucophage. Patients who currently use Glucophage will not be switched to Avandia. "We do not see this as a big contradiction," Garnier said. As part of the deal, the two companies would share profits generated by Avandia. SmithKline may also get the chance to co-promote a future Bristol-Myers drug.
Diabetes Drug ACTOS Appears Safe For LiverLiver safety data for Aptos, Takeda Pharmaceuticals America, Inc's new diabetes drug, were presented by researchers to the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA). The data showed patients taking Actos(TM) (pioglitazone hydrochloride) tablets had no significant difference in the elevation of liver enzymes compared to patients on placebo. Neil Kaplowitz, M.D., chief, Division of Gastrointestinal and Liver Disease, University of Southern California, and James W. Freston, M.D., Ph.D., professor and director, Office of Clinical Research, University of Connecticut Health Center. America Research and Development Center, Inc. presented the data. Efficacy and safety data from clinical trials involving approximately 2,600 patients in the United States were submitted to the FDA for review. The participants were given doses of Actos once a day. Data of the glycosylated hemoglobin (HbAlc) as a marker of long-term glycemic control, fasting blood glucose and serum lipids were collected. The data showed that elevated liver enzymes occurred in 0.26 percent of Actos-treated patients and in 0.25 percent of patients taking a placebo. No jaundice or liver failure in any clinical studies to date were reported. The majority of side effects reported during clinical trials were mild infections and headaches. Takeda filed a new drug application (NDA) for Actos for Type 2 diabetes with the FDA in January 1999 for four uses: as monotherapy, or in combination with sulfonylureas, metformin or insulin. ACTOS received priority review from the agency in March 1999. Roberta L. Schneider, M.D., vice president, Drug Development, Takeda America Research and Development Center, Inc. says, "We are confident that efficacy data for the compound also will help the FDA complete the Actos review in a time frame consistent with the priority review process." When FDA approval is received, Takeda will cooperate with Eli Lilly and Company to promote Actos. The drug reduces insulin resistance increasing the body's ability to use its own insulin.
Who Is Disabled?Since the American Disability Act was passed in 1990, many people have gained access to public buildings and facilities and in many instances job discrimination has been banned. Now the Supreme Court is attempting to clarify the contradictions and confusions in the interpretations of the Act. Three landmark cases they are hearing in this current term will further define areas of the ADA. What does "disabled" mean? Who is covered by the act? The court's eventual rulings will define who is protected under the Act: just the severely disabled, or millions more with contact lenses, high blood pressure, diabetes or hearing aids. In these three cases, the justices will face critical questions at the heart of the historic law regarding employment. Lower courts have come down on both sides of the law. The first care involves Vaughn Murphy, who was fired from his job as a United Parcel Service mechanic in 1994 after a company nurse noticed the high blood pressure he's had since childhood exceeded federal guidelines. Murphy had had his commercial driver's license for years, and had gotten a Dept. of Transportation health certificate. UPS decided his health approval was issued in error and fired him. He sued, saying the company was discriminating against him because of his disability, his high blood pressure. The company's lawyers argued that Murphy's high blood pressure didn't qualify him, under the law's requirements, as having a disability and that, besides, hypertension didn't substantially limit a major life activity, another requirement for protection under the statute. Karen Sutton and Kimberly Hinton, severely nearsighted twin sisters, sued United Airlines for rejecting them from jobs as pilots. Their case comes before the court second. The third case involves Hallie Kirkingburg, who has poor vision in one eye. He sued Albertson's grocery stores after they fired him from a truck driving job. According to a study conducted by the American Bar Association, employers have won 92 percent of the 700 ADA cases resolved in court from 1992 to 1997. But now employers fear that victories by the workers in the Supreme Court cases could lead to a flood of new lawsuits.
COX-2 Inhibitors Kill Pain With Fewer Side EffectsCelebrex, the first of a new type of painkiller, developed by Monsanto's G.D. Searle & Co. pharmaceutical unit and co-marketed by Pfizer Inc, was put on the market last month. This drug is the result of new insights into the biochemistry of pain. It is not a more effective painkiller than aspirin or ibuprofen, which are non-steroidal anti-inflammatory drugs (NSAIDs). But it is a major breakthrough for people who must use pain relievers that typically cause irritation of the stomach and intestinal tract, stomach bleeding and ulcers, because Celebrex has fewer side effects. Why do Celebrex and other drugs of this new type called COX-2 inhibitors work better? COX-2 drugs block production of an enzyme which produces painful inflammation. NSAIDs do too, but they also interfere with the closely related COX-1 enzyme, which helps protect the lining of the stomach and gastrointestinal tract. The COX-2 drugs do not interfere with COX-1. The good news is that more COX-2 inhibitors, are queing up to come on the market. Another drug of this same type, Merck & Co.'s Vioxx, is awaiting approval by the Food and Drug Administration and could be on the market by summer. The not-so-good news is that Celebrex is expensive, $2.42 per 200-milligram pill, which is more than HMOs might be willing to pay. COX-2 drugs are designed primarily for people with rheumatoid arthritis (2.1 million people in US) or osteoarthritis (20.7million in US). Because of the expense they may not be prescribed for people who have a problem with NSAIDs unless they have arthritis. Other new pain fighters of other types: Enbrel, a new rheumatoid arthritis medicines called a biologic response modifiers, soaks up excess "tumor necrosis factor," a chemical secreted by immune cells involved in joint inflammations. The drug, made by Immunex Corp. of Seattle, was approved by the FDA last year for use in adults. New studies show that it also may be effective in childhood forms of arthritis. (Incidentally, nicotinamide, a relative of niacin, one of the B vitamins, also blocks tumor necrosis factor. TNF reduction is also believed to be a major mechanism by which drugs like Rezulin are believed to inprove insulin sensitivity. It is not known if COX-2 inhibitors have any blood sugar lowering effects.) Neurontin, known generically as gabapentin, was developed for epilepsy but it has been shown to work against nerve pain from shingles or diabetes. Tests are under way to establish whether memantine, a drug which blocks NMDA receptors or nerve cell sites that help relay pain signals, can ease the pain of diabetic neuropathy.
Education About Impotence Still NeededA new nationwide survey of 1,035 men and women sponsored by the Impotence World Association shows that only five percent of people surveyed knew that physical reasons cause most erectile dysfunction (ED). This means that the majority of people are unaware that experts have found that 80 percent of ED cases are the result of serious medical conditions, such as diabetes, hypertension or prostate cancer surgery, while the remaining 20 percent of cases are due to psychological factors, or a combination of both. ED is often a sign that a serious health problem is occurring. Also under 15 percent of those surveyed were aware of treatment medications other than Viagra. In contrast, more people were aware of non-prescription treatments, including penile implants (46 percent) and vacuum pumps (36 percent). People who are unable to take Viagra or for whom it is not effective need education to know all the current treatment alternatives to Viagra. These include medications like alprostadil, a prostaglandin-derived product that is administered via injection (Caverject(R), sterile powder, Edex(TM)) or intraurethrally (MUSE(R)), vacuum constriction devices, and, for more severe cases, surgical prostheses. The full range of options makes success more likely and give the possibility of finding a treatment that the man and his partner are comfortable with. To become aware of all the options, a medical expert is often needed. The study found that those surveyed would prefer to receive treatment for ED from their primary care physician, despite their belief that urologists are the experts. Urologists are trained to inform men about treatment options, advise them on how long to try an option, and assist them through the process until they find a solution. In the survey, 467 men and 568 women were interviewed by phone between April 9th and 11th. The survey was sponsored by an unrestricted educational grant provided by Pharmacia & Upjohn but created and conducted by the Impotence World Association, which is a non-profit, educational and charitable international health association. Those interested in more information on impotence and treatments can call 800- 669-1603 or visit the Impotence World Association website.
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