All Eyes on Alli vs. Obesity Match-Up – Over-the-Counter Weight Loss Drug That Packs a Punch

The launch of Alli (Orlistat) – the first FDA-approved over-the-counter anti-obesity drug – is exciting news for millions of obese and seriously overweight Americans. Alli, which is expected to hit drugstore shelves this summer, is comprised of a reduced-strength formula of the popular weight-loss drug Xenical (orlistat) and is the only weight-loss drug endorsed by the U.S. Food and Drug Administration and made available without a prescription.Pharmaceutical giant and Alli manufacturer GlaxoSmithKline maintains the product rights to Alli through mutual agreement with Roche, the manufacturer of prescription-only Xenical. Xenical has a steady safety record and has proven to be moderately effective in helping obese individuals lose weight. Studies indicate that when patients take prescription Xenical in combination with a weight-loss program, patients lost an average of 12.4 pounds of weight less in six months — about double the amount lost by patients taking a placebo weight loss drug. Some studies have suggested that Alli, at half the dosage (and approximately one-third the price of prescription Xenical,) is almost as effective.How it WorksAlli is made of the same chemical structure as Xenical. The drug obstructs dietary fat from being absorbed by the body after food consumption. The undigested fat is then removed from the body as bowel waste. As such, the drug it leads to a reduction in the absorption of fat by as much as 30%.
Alli will be available in 60 milligram capsules, to be taken three times a day with meals that contain fat. Officials at GlaxoSmithKline said that the drug works by “blocking about 25 percent of the fat in food a person eats. Because of the way it works, Alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal.” GlaxoSmithKline also reported that the drug helps people lose 50 percent more weight than dieting alone. Alli will cost consumers $12 to $25 a week.
“This is the only FDA-approved, over-the-counter weight-loss drug product,” Dr. Charles J. Ganley, the FDA’s director of the Division of Over-The-Counter Drug Products, said during a teleconference. “There are some products, primarily dietary supplements, that make weight-loss claims and those are not FDA-approved, although they are permitted to make these claims.”Alli vs. The U.S. Obesity EpidemicThe FDA’s approval of the first over-the-counter drug for weight loss comes as the United States and other Western nations are struggling with an unprecedented obesity epidemic. According to the U.S. National Center for Health Statistics, 30 percent of American adults 20 years of age and older — more than 60 million people — are obese. An Additional 36 percent of Americans are considered overweight.But is Alli the magic diet pill that dieters have been asking for? Maybe not, according to some researchers. Dr. Raj Padwal, an assistant professor of general internal medicine at the University of Alberta, is unsure of about the efficacy of the drug. “People may only lose 1 to 2 kilograms (2.2 to 4.4 pounds) on this half-strength dose [of Xenical]. Whether that is worthwhile is questionable,” said Padwal. “The occasional patient may benefit, but many patients may not. For those patients who need extra incentive to adhere to a low-fat diet, the drug may help.”Alli is likely to cause very limited direct harm, but may also cause limited good, according to Dr. David L. Katz, an associate professor of public health and director of the Prevention Research Center at the Yale University School of Medicine. “[Alli] is a relatively ineffective weight-loss aid,” he said. “If availability of the drug distracts people from the tried-and-true approach to weight control – eating well and being active – then the FDA decision could prove more harmful than helpful, in spite of good intentions.”Side EffectsAccording to research and trials, Alli has very few negative side effects. However, users be warned: eating a meal with too much fat while taking the drug can result in bowel changes such as loose stools, according to the FDA. Side effects typically occur in the first weeks of treatment and can be managed by following the recommended diet of about 15 grams of fat per meal, GlaxoSmithKline said. It is also recommended that users take a multivitamin once a day at bedtime because the drug can interfere with the absorption of some vitamins.
Other side effects may include:o Oily skin spottingo Gas with dischargeo Fecal urgencyo Fatty or oily stoolso Frequent bowel movementsBefore Taking AlliPrior consultation with a doctor is recommended before taking Alli. Be sure to:o Tell your doctor or pharmacist if you are allergic to orlistat or any other drugs.o Tell your doctor or pharmacist what prescription and nonprescription drugs you are taking, especially anticoagulants (”blood thinners”) such as warfarin (Coumadin); medications for diabetes, such as glipizide (Glucotrol), glyburide (DiaBeta, Dynase, Micronase), metformin (Glucophage), and insulin; other medications for weight loss; pravastatin (Pravachol); vitamins such as beta-carotene and vitamins A, E, and K; and herbal products. If you are taking cyclosporine (Neoral, Sandimmune), take it 2 hours before or 2 hours after orlistat.o Tell your doctor if you have or have ever had anorexia nervosa or bulimia, gallstones, thyroid disease, diabetes, kidney problems, or if you consistently have problems absorbing food (malabsorption syndrome).o Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.o Inform your doctor about your medical history including drug or alcohol abuse in order to avert any medical mishap.Also, people who have had an organ transplant should not take the Alli. Anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using the drug, the FDA said.
Is Alli the end-all treatment that will fight the obesity epidemic once and for all? Studies indicate that it may certainly help, yet skeptics are equally as weary about its overall effectiveness. If you are considering taking Alli when it hits the shelves this summer, be sure to consult with your physician first.

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The Whole Truth About Sunlight, Cancer and Sunscreens

Humans have been living on this Earth for at least four million years. The sun has been shining for about 4.6 billion years and it has been shining on our Earth for most of that time. Strangely, no animal ever contracted skin cancer from being out in the sun and humans rarely did until about 50 years ago.We have been told that this increase in skin cancer is due to a “hole” in the ozone layer. Actually there is no “hole”. However, the ozone layer is thinning in some areas, predominately at the South Pole in the fall and winter seasons. The ozone layer, approximately 10 kilometers (6 miles) above the earth, acts as a shield to prevent dangerous radiation from reaching the biosphere. There is also a minor amount of thinning in the northern hemisphere and little or none in the tropics.The incidence of all forms of skin cancer are highest in the tropics, where there is virtually no thinning of the ozone layer.In 1991 Professor Johan Moan of the Norwegian Cancer Institute found that the yearly incidence of melanoma in Norway had increased by 350% for men and by 440% for women between 1957 and 1984. He also determined that there had been no change in the ozone layer over this period of time. He concludes his report in the British Journal of Cancer by stating: “Ozone depletion is not the cause of the increase in skin cancers”. Unless these folks spent a fair amount of time hanging out in the Antarctic wearing bikinis, he is probably correct.Skin cancer has increased all over the world, about 90% in the USA from 1974-1990. This skin cancer increase is too large (90%) compared with the expected value (40%) from ozone depletion. Also, cancer does not develop immediately after exposure to the sun. The sunburns may occur within hours, but cancer development and detection may take years or decades. If the depletion of the ozone layer over Antarctica is not causing the huge increase in skin cancer, what is?It is interesting to note that chemical sunscreen was introduced in the late 1920′s and by 1936 the first commercially available sunscreen product was being sold by L’Oreal. Also, Monsanto began producing artificial chemicals in 1901. Why is this bit of information important?First, let’s take a look at our skin, and the damage we do to it before we even go out into the sun.There are an estimated 250 species of bacteria that reside on your skin. They are there for a reason. Sebum, secreted by the sebaceous glands in the skin, is an oily substance composed of wax monoesters, triglycerides, free fatty acids and squalene, and again, it is there for a reason. These bacteria and oily substances PROTECT the skin. We seem to have invented endless ways to destroy this protective barrier starting with the water we bathe, shower and swim in. A survey by the Environmental Working Group found 141 unregulated chemicals and an additional 119 for which the Environmental Protection Agency has set health-based limits. Most common among the chemicals found were disinfection byproducts, nitrates, chloroform, barium, arsenic and copper, and of course chlorine, fluoride and PCBs ,THMs and heavy metals. These chemicals not only strip the skin of its natural protection, they are absorbed through the skin and into the bloodstream where they continue to cause damage.We also have a tendency to destroy this protective barrier with various chemicals and soaps. We slather our skin with every toxic chemical imaginable, most of which gets absorbed into our bloodstream. There are over 150 cancer-causing chemicals currently used in cosmetics. Although federal law requires products containing these ingredients to carry a written warning label, the FDA does not enforce this law. The FDA claims that these products are safe because they are not consumed orally. Can it be possible that the folks at the FDA are not aware of the many drugs that are administered through the skin because the skin is porous and allows most drugs and chemicals to be absorbed?You would be amazed to find what the FDA allows to be sold as long as it says, “for external use only.” The assumption is that it will stay external and not be absorbed into the body, so its toxicity is irrelevant. Hello!! Who are we kidding? Sunscreen ingredients absorb into the blood, and most are linked to toxic effects. Some release skin-damaging free radicals in sunlight, some disrupt hormone systems, several are strongly linked to allergic reactions, and others build up in the body or the environment. According to the Environmental Working Group only 15% of 952 products analyzed actually block UVA and UVB radiation, remain stable in sunlight, and contain few toxic chemicals.Here is a short list of some of the stuff we regularly put on our skin without a second thought. The toxic effects recognized by the FDA are included:OXYBENZONE (BENZOPHENONE-)
(Active Ingredient)858%Developmental/reproductive toxicity, Violations, Restrictions & Warnings, Allergies/immunotoxicity, Persistence and bioaccumulation, Enhanced skin absorption, Biochemical or cellular level changesPEG-100 STEARATE 479%Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Contamination concerns(ETHYLENE OXIDE 1,4DIOXANETRIETHANOLAMINE767%Cancer, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Contamination concerns(NITROSAMINES) MICRONIZED ZINC OXIDE
(Active Ingredient)276%Violations, Restrictions & Warnings, Persistence and bioaccumulation, Occupational hazardsTITANIUM DIOXIDE 173%Organ system toxicity (non-reproductive), Occupational hazards, Biochemical or cellular level changes(HYDROQUINONE)OCTINOXATE (OCTYLMETHOXYCINNAMATE)
OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE)
(Active Ingredient)478%Allergies/immunotoxicity, Persistence and bioaccumulation, Enhanced skin absorption, Biochemical or cellular level changesBUTYLPARABEN 477%Developmental/reproductive toxicity, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Biochemical or cellular level changesThere are HUNDREDS more but I don’t want to bore you here, just WAKE you up!! Is it logical to cover yourself with this stuff, then go out into the sun and let it bake in? Geez, you can cause untold damage to your largest external organ AND your internal organs simultaneously!The sun is NOT your enemy! Sure, in some areas at some times you will have to spend less time in the sun to avoid getting burned, but sunlight is VITAL. Sunlight allows your body to produce natural vitamin D and increased melatonin, both of which are essential.Vitamin D levels are linked to survival rates for cancer patients. Those people who live in sunnier southern latitudes and have higher vitamin D levels are less likely to die from cancer than people in northern latitudes.Rates of major cancers such as colon, lung, breast and prostate increased from north to south, while survival rates decreased from north to south.Vitamin D may protect against cancer by discouraging out-of-control cell reproduction and hindering the formation of new blood vessels for tumors. Receptors that respond to vitamin D have been found in almost every cell in your body, from your brain to your bones. Optimizing your vitamin D levels, (through safe sun exposure) could help you to prevent as many as 16 different types of cancer including pancreatic, lung, breast, ovarian, prostate, and colon cancers. Vitamin D does not just impact your cancer risk slightly; it can cut your risk by as much as 60 %.This is not to say that you should not be cautious. A severe burn is obviously damaging. However, a mild sunburn is not dangerous as long as the skin has been allowed to retain its natural protective barrier and is not marinated in a chemical cocktail. A slight sunburn is your body’s natural way of letting you know that it’s time to get out of the sun, it also helps to remove the outermost layer of dead skin with fresh new skin, thus reducing wrinkles! People pay money for this, it’s called “dermabrasion” and “chemical peels”, you can have it done naturally at no charge by getting a mild sunburn.Sunlight is vital to almost every living organism, and is our greatest ally in sustaining good health.

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