Pharmabiz
 

New Drug to reduce frequency of women's' periods

Dr VenkatAppaji PadmanabhuniWednesday, October 8, 2003, 08:00 Hrs  [IST]

A new birth-control pill named Seasonale promises to reduce the frequency of women's periods, from every month to four times a year. The contraceptive pills, approved by the US Food and Drug Administration are not a new chemical. It contains the same combination of low-dose estrogen and progestin found in many oral contraceptives. For decades, many doctors have told women how to skip a period by continually taking the active birth-control pills in each month's supply and ignoring the week of dummy pills in each packet. Seasonale promises to make the option a little more convenient, with packaging that gives women 12 straight weeks of active pills and then a week of dummy pills for their period. Substance from Lizard's Saliva Controls Diabetes & weight Exenatide, an experimental diabetes drug derived from lizard saliva, not only controls patients' blood sugar levels but also cuts their weight. Amlyn Pharmaceuticals and Eli Lilly released new study findings on the efficacy of exenatide at the 18th Congress of the International Diabetes Federation in Paris. The drug, derived from the saliva of a lizard known as the Gila monster, is the first in a new class of therapies for type 2, or adult-onset, diabetes and is on track to be submitted for approval by regulators in 2004.The Gila monster lizard lives in the Arizona desert, only eating about four times a year. Its salivary secretions help prevent a sudden surge in blood sugar levels Medicine prices in US become an important political issue The United States is hugely important for drug companies. The pharmaceutical market is worth more than $150bn (Rs 690000 crores) and annual spending has been rising by almost 20% a year. . Prices are not regulated in the way they are in many other countries, and companies are allowed to advertise directly to consumers-so boosting consumption. But now the cost of drugs has become an important political issue, and a bill has been introduced into Congress that would require government agencies to gather evidence "comparing effectiveness [and] cost effectiveness" of the most commonly prescribed drugs "relative to other drugs or treatments for the same disease." The bill aims to reduce costs, but it could also improve quality. The proposal is to conduct many more head to head trials of common treatments-trials like the ALLHAT (antihypertensive and lipid lowering to prevent heart attack trial), which showed that diuretics are just as good as much more expensive drugs for treating hypertension. The whole world stands to benefit from such trials. The industry is lobbying against the bill, but its problems are much deeper than congressional irritations. The industry has been increasing sales by 12%-15% for 30 years with half of the increase coming from raised prices. Now globalisation and political endeavours are making such price increases impossible. Exercise and Vit E Combo Provide Better Defense Against Aging It is known that exercise is a great way to prevent or delay age-related diseases such as heart disease, cancer, and Alzheimer's. But combining exercise with Vitamin E use shall provide a better defense than either strategy alone against several ailments caused or worsened by age, according to a study published in Biological Research for Nursing. Whether they exercised or not, those taking vitamin E pills had the same reduction in harmful substances known as free radicals -- unstable molecules that damage cells and are believed to contribute to the development of some 200 different diseases, many of them age-related. The levels of a blood marker that signals free-radical damage were cut in half. But exercise provides its own protection -- boosting antioxidant substances that combat these free radicals. It also reduces risk factors such as obesity, hypertension, and diabetes that worsen free-radical cell damage. "The conclusion is that a combination of moderate exercise and vitamin E is the most effective way to go. Other research indicates that vitamin E also improves lung function in those who work out when the air quality is poor. FDA approved Saliva Ovulation Tester launched Saliva has been proven as a reliable indicator of ovulation. TCI Optics U.S.A, announced that their FDA-approved natural ovulation device is now available in market. This new tester allows women to view their saliva and accurately predict ovulation. No bigger than a compact case, the OvuLook is a hand-held, reusable microscope that allows women to see a unique pattern in their saliva called ferning. Based on the rise and fall of the hormone estrogen, this ferning pattern looks like frost on a windowpane. This distinctive pattern develops in saliva around the time of ovulation. A woman simply places a drop of saliva onto the OvuLook device, lets it dry and looks through the eyepiece. The OvuLook is the first tester of its kind to be approved by the FDA. Generic biologics raise new issue of regulation as Patents Expire Biotech drugs are so complex to make that the question of generic versions has not been fully addressed. The first patents on biologics are beginning to expire, and generic drug makers are moving in. Meanwhile, consumer groups and patients are hoping for relief from the cost of branded products, which sometimes run higher than $100,000 a year. It would take federal legislation to establish the necessary approval mechanism for generic biologics. Beginning in 2005, most biologics will begin losing their patents. Already off patent are human growth hormones, insulin, beta interferon and alpha interferon, which together command worldwide sales of $13.5 billion. So far, only Novartis, Teva and Merck KGaA are regarded as having the expertise and resources to delve into the manufacture of such complex medicines. Industry scientists noted that the generic drug makers will have to conduct the same testing for generics as for the original products since "the slightest change in a bioengineered product, they say, can elicit a different--and sometimes harmful--response,". Agreement to cut the costs of drugs for poor countries The landmark agreement to cut the costs of drugs for poor countries, agreed in Geneva on 30 August, is intended to help the countries tackle public health crises, especially HIV/AIDS, tuberculosis, and malaria in sub-Saharan Africa. The deal covers all patented products or products made using patented processes in the pharmaceutical sector, including active ingredients and diagnostic kits. Under the new deal reached by the Trade-Related Aspects of Intellectual Property (TRIPS) Council of the World Trade Organization (WTO), they will be able to. Exemptions agreed under the deal for the least developed countries are valid until 2016. Major requirements of the arrangement: · The government of a poor country asks another country such as India or South Africa that has a generic drug manufacturing industry to issue a compulsory licence to one or more of its manufacturers to produce a particular drug or pharmaceutical product. · The country with the manufacturers tells the TRIPS Council which product it intends to export, to which country, and in what quantity, and it must specify the type of packaging to ensure that the drugs are easily identifiable as copies of patented products. · When the TRIPS Council has received this information WTO member states may ask questions and may even object, under the terms of the TRIPS agreement. Once the manufacturer gets the go ahead it will need to conduct research before being able to make copies of patented drugs. The manufacturer will then be able to produce cheaper copies of the patented products and export them to the country or group of countries that requested them. Appetite-Suppressing Hormone Increasing levels of an appetite-curbing hormone may help obese people eat less at meals. A British study published in the New England Journal of Medicine finds that the hormone PYY3-36, which is naturally produced in the digestive tract, helps both lean and overweight people eat less. In the study, researchers had 12 obese and 12 lean people eat two buffet meals, one after they'd been given a dose of synthetic PYY hormone and once after they were given a placebo injection. After an intravenous dose of PYY, both the obese and the lean people in the study ate 30 percent fewer calories than with the placebo. The researchers also found lower natural levels of the hormone in obese people, suggesting a possible cause of overeating, The Associated Press reports. The researchers say more study is needed before injections of PYY could be considered as a possible treatment for obesity. But they say that a high-fiber diet naturally increases the body's production of PYY. News Virus Causing Colds Discovered A recently discovered virus may be the culprit in many cases of the common cold. In a study presented this week at the American Society for Microbiology meeting, researchers say the metapneumovirus virus is extremely common and widespread, and may be responsible for many colds in adults and more serious coughing and congestion in children. They say that although the virus was discovered only two years ago, it has probably been around for a very long time, The Associated Press reports. It rarely is serious, but the researchers say it can cause severe illness in young children, the elderly, and people with certain medical conditions. The study looked at nasal specimens taken from 2,000 children with lower respiratory infections. The researchers found metapneumovirus in 12 percent of the samples from kids with severe infections and in 14 percent of the samples from kids with milder colds -- making it the second most common cause of respiratory illness in children, the AP says. Several teams of researchers are now studying the virus to see how often and how severely it affects adults, the AP says.

 
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