Monthly Archives: July 2013

Factor4 vs Diet Pills

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This Article published recently in the NY times reviews the latest Diet Pills but leaves out all the information on Side Effects! Factor4 has no side effects, is not a Pharmaceutical and works naturally to restore your metabolic system resulting in healthy weight loss and over 50 healthy benefits! Which would you choose?

Few Signs of a Taste for Diet Pills

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Published: July 1, 2013

Americans spend tens of billions of dollars each year to lose weight — gym memberships, Weight Watchers and other programs, operations, nutritional supplements and whatever the latest diet fad might be.

But the first new prescription weight-loss drug to reach the market in 13 years is having a hard time winning even a tiny slice of that huge market, despite an apparent need.

Sales of the drug, Qsymia (pronounced Kyoo-sim-EE-ah), have been minuscule since it went on sale last September. Sales totaled only $4.1 million in the first quarter of this year, even as Vivus, the manufacturer, spent $45 million on marketing, sales and administrative expenses.

Vivus’s stock price has plunged to $12.41 from $29 on the day after Qsymia was approved last July. And the company’s largest shareholder, saying the drug’s introduction was horribly botched, is battling to oust the entire board and top management at Vivus’s annual shareholder meeting on July 15.

More than a corporate drama, however, the slow start of Qsymia raises questions about what role prescription drugs really can play in combating the nation’s epidemic of obesity.

While there are some problems unique to Qsymia, it is also facing barriers that are likely to confront other weight-loss drugs as well, including Belviq, a drug from Arena Pharmaceuticals and Eisai, that went on sale last month. Another drug, Contrave from Orexigen Therapeutics, is in advanced clinical trials.

These obstacles include lack of insurance reimbursement, modest weight loss, safety concerns, the troubled history of diet drugs, and a feeling on the part of many doctors and obese people themselves that excess weight is a lifestyle issue best addressed by more willpower, rather than a disease that requires medical treatment.

“You’ve got this turning of the battleship to change how the medical community views obesity,” said Dr. Barbara Troupin, vice president for scientific communications and risk management at Vivus.

The attitude is turning at least a little. Last month, the American Medical Association, the nation’s largest group of doctors, declared obesity a disease. In April, the American Association of Clinical Endocrinologists included weight-loss drugs in its diabetes treatment guidelines.

Given that one-third of American adults are obese and another third merely overweight, an effective and safe diet pill would seem like the path to instant riches. Jack Lief, the chief executive of Arena Pharmaceuticals, said in 2009 that sales of obesity drugs could eclipse those of statins, the cholesterol-lowering pills like Pfizer’s Lipitor, which had peak annual sales of about $13 billion before falling to generic competition.

Yet no prescription drug for obesity has ever reached annual sales of even $1 billion, the lower boundary of what the pharmaceutical industry considers a blockbuster.

While it is estimated that more than two million people take weight-loss drugs, the vast majority using the old generic appetite-suppressor phentermine, that is still only a tiny fraction of the 70 million or more obese adults.

And patients typically give up on the drugs quickly. An analysis of prescription data by the Food and Drug Administration found that only one quarter of people kept using a drug for at least three months, and only 10 percent for at least 180 days.

One reason is that many people don’t lose much weight. The clinical trials showed that those taking the recommended dose of Qysmia lost an average of 7.8 percent of their weight after a year. At that rate, a 250-pound person would end up at about 230 pounds.

Some people can do better than average, however. Marty McNamara, who started taking Qsymia in November, said he had dropped from 424 to 332 pounds as his appetite has virtually disappeared. Mr. McNamara, a 6-foot 5-inch highway maintenance worker from Ridgecrest, Calif., said he now eats only fruit for lunch.

“It’s amazing, because I like food,” he said, but quickly corrected himself. “I used to like food.”

Diet pills have been plagued by safety issues that have marred the image of the class. Two drugs used as part of the popular fen-phen combination were taken off the market in 1997 for damaging heart valves. In 2010, Abbott’s Meridia was withdrawn after a study suggested it might raise the risk of heart attacks and strokes.

Neither Qsymia nor Belviq has won approval in Europe, in part because of safety concerns. And Consumer Reports advises people to skip what it calls “quick-fix weight-loss drugs” because “their benefits are usually minimal and their adverse effects can be troublesome.” It urges people to lose weight the tried-and-true way, by dieting and exercising.

The main safety concern with Qsymia is that it might cause birth defects. For that reason, the F.D.A. required that the drug be distributed through only a handful of mail-order pharmacies, a cumbersome process for doctors and patients. Recently, however, the agency agreed that qualified retail pharmacies could also dispense the drug. Vivus said on Monday that Qsymia was now available through 8,000 retail drugstores, removing a major barrier to sales.

“I feel we have been held in check driving around the pit lane, without being able to go out and put this formula racecar to the test,” said Peter Y. Tam, the president of Vivus, which is based in Mountain View, Calif.

But there are still other roadblocks. Medicare Part D does not cover weight-loss drugs, although a bill was just introduced to change that. Only about one-third of Americans with private insurance have coverage for the drug, but often with co-payments of $50 a month or more. People without coverage will pay at least $150 a month.

“Most people don’t find that amount of money is worth it for that amount of weight loss,” said Dr. Ethan Lazarus, a weight-loss specialist in Denver. Dr. Lazarus said that only about five of his 600 active patients were on Qsymia.

Qsymia is a combination of two generic drugs, phentermine and topiramate. Dr. Lazarus said he sometimes prescribed the two generic drugs, which can cost as little as $40 a month.

The drug companies and other backers of the drug make the case that since obesity contributes to numerous other ailments like diabetes and heart disease, use of the pills to lower weight might actually produce a net savings for insurers, patients and Medicare.

Because of the cost and cumbersome distribution system, when Qsymia first went on sale, as many as 30 percent of the prescriptions were abandoned before being filled.

To counter that, Vivus is now offering the first two weeks of Qsymia free and is limiting out of pocket costs to $75 for the next month. It hopes that by the end of the first six weeks, people will have started to lose enough weight to stay on the drug.

Terri Baker of Houston is approaching that point now. Ms. Baker said she had not lost any weight yet, but said the drug made soda taste flat to her, allowing her to break her soft-drink habit. She plans to give the drug some more time, even though it will now cost her $150 a month.

“I really want to try this,” said Ms. Baker, who is 52 and weighs 200 pounds. “Nothing else has worked.”

Another problem for Qsymia is lack of resources. Vivus has only 150 sales representatives, far too few to reach primary-care physicians. Its disgruntled biggest shareholder, the First Manhattan Company, says one of Vivus’s biggest mistakes was not to enlist a big pharmaceutical company to help it sell the drug.

Vivus executives say they planned to target mainly endocrinologists first, but are now talking with larger pharmaceutical companies. They also say the company plans to start direct-to-consumer advertising in the fall.

Meantime, the company saysthat its strategy is falling into place, with retail pharmacies coming on line and organizations like the Veterans Health Administration and pharmacy benefits manager Express Scripts agreeing to pay for the drug.

Qsymia had been prescribed by 15,000 doctors to 40,000 patients as of the end of March, the company says, but prescriptions have risen since then.

Replacing the board with First Manhattan’s slate, it argues, would only “throw Vivus into turmoil at a critical juncture.”

First Manhattan, which owns 9.9 percent of Vivus, disagrees, saying in one letter to shareholders: “The light at the end of the current ‘stay the course’ tunnel is an oncoming train.”

A Label Calls Attention to Obesity

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Factor4 is the right solution at the

right time and it’s time is now!

Dr. George Scheele has the answer to

the Obesity Epidemic!

A Label Calls Attention to Obesity

By JANE E. BRODY

Most people know that obesity can result in serious health problems, yet many of us continue to focus on its cosmetic consequences rather than its risks to health.

This distorted view may change now that the American Medical Association has finally labeled obesity a disease, not just a risk factor for other disorders. Last month, the organization recognized that obesity is a verifiable illness that warrants far more attention than physicians, patients and insurers currently give it.

The designation may change how aggressively doctors treat obesity, foster the development of new therapies, and lead to better coverage byinsurers. After all, the price of not treating obesity is now in the stratosphere. Obesity-related health conditions cost the nation more than $150 billion and result in an estimated 300,000 premature deaths each year.

If the population’s weight gain is not soon capped (or better yet, reversed), experts predict that half of adults in America will be obese by 2040. The A.M.A. has said in effect that it is medicine’s responsibility to provide the knowledge and tools needed to curb this runaway epidemic.

On June 19, James Gandolfini, the hefty award-winning actor who portrayed Tony Soprano in “The Sopranos,” died at 51, apparently of a heart attack, while on vacation in Italy. Even if genetics played a role, Mr. Gandolfini’s weight contributed significantly to his risk of sudden cardiac death.

Not a week earlier, a 46-year-old member of my family who weighed over 300 pounds died suddenly of what might have been a heart attack while dozing in front of the television. He had long suffered from sleep apnea (a risk factor for sudden death), high blood pressure and severe gout, all results of his extreme weight.

Fran Saunders, a 62-year-old Brooklynite, is determined to avoid a similar fate. At 4 feet 11 inches tall and 157 pounds, she was clinically obese. She was sent for blood tests when she complained of a vision problem that could have been related to her weight. All her lab readings — total cholesterol, triglycerides, blood sugar — were seriously abnormal. Her doctor said she was a heart attack waiting to happen. But “the bad news was a blessing in disguise,” she told me.

Though she had long been a regular at the gym, she knew it was time to get her diet on a healthier track to lower her cholesterol, her risk of developing diabetes and her chances of dying prematurely.

She now monitors what she eats and how much she exercises with a free cellphone app, My Fitness Pal. Gradual weight loss started almost overnight at a pound or two a week. Although her goal weight is 110 to 115 pounds, her blood test results improved significantly after she lost just seven pounds.

“My doctor told me that every pound I lose lowers my risk,” said Ms. Saunders. “I know it’s possible for some people to be fit and fat, but that wasn’t the case for me, and it was time to stop kidding myself.”

The list of problems obesity can cause should be a call to action for the one-third of American adults who are obese. Heart Disease and Stroke Obesity can raise levels of artery-damaging triglycerides and LDL cholesterol, and lower levels of protective HDL cholesterol. This raises the risk of atherosclerosis tenfold by fostering a buildup of plaque in arteries that feed the heart and brain. The chest pains of angina occur when the heart cannot get enough oxygen-rich blood through plaque-clogged arteries. A piece of plaque can break off at any time and block a narrowed artery, causing a heart attack or stroke.

Obesity also strains the heart and can lead to heart failure — a heart unable to pump the blood necessary to supply the body with adequate oxygen and nutrients.

High Blood Pressure Excess body fat increases the volume of blood the heart must pump to supply all tissues with nutrients and oxygen. This increases the pressure on artery walls, which contributes to heart disease, stroke and kidney failure.

Type 2 Diabetes Obesity impairs the body’s ability to use insulin to maintain normal blood sugar levels. Diabetes, in turn, is a leading cause of heart disease, stroke, kidney disease and blindness. Once a late-in-life disease, Type 2 diabetes now is often seen in overweight children. Even being moderately overweight can lead to insulin resistance, in which the body becomes insensitive to the hormone. The condition can be reversed by weight loss.

Joint Disease The more weight a person carries, the greater the stress on joints and the risk of developing painful, incapacitating osteoarthritis in the knees, hips and lower back. Obesity is a major reason for the sharp rise in costly joint replacements. Excess weight can also cause premature failure of an artificial joint.

Breathing Problems In addition to causing shortness of breath during physical exertion, obesity is the leading cause of obstructive sleep apnea — breathing stops periodically during sleep, followed by an abrupt intake of air and loud snoring. Apnea disrupts sleep and results in daytime drowsiness that can cause accidents.

Cancer People who are obese are at increased risk of developing cancers of the colon, breast, endometrium, esophagus, pancreas, kidney, thyroid and gallbladder. One possible reason: increased amounts of growth factor in obese people may promote tumor development. Metabolic Syndrome One-third of overweight and obese people have a constellation of six factors that seriously raise the risk of cardiovascular disease: abdominal obesity, high blood pressure, high cholesterol, insulin resistance, excessive clotting factors and inflammatory compounds in the bloodstream. Abdominal fat is especially hazardous because it is metabolically active, unlike relatively inert fat on the hips and thighs.

The list of obesity’s hazards goes on: infertility in women, pregnancy problems, gallstones and gout, not to mention emotional disorders, social ostracism and employment discrimination.

The first step toward avoiding all of these is a simple calculation to determine whether you are at risk. The most frequently used measure is body mass index, calculated by dividing weight in kilograms by height in centimeters squared. The National Heart, Lung and Blood Institute, among others, offers a free calculator online. In general, a B.M.I. of 30 or more indicates obesity, but B.M.I. can be misleading if heavy bones and big muscles account for a large portion of someone’s weight.

A simpler measure is a waistline as large as or larger than a person’s hips. Overweight typically starts at a waist of 40 inches for men and 35 inches for women.

The easiest assessment of all? Stand naked in front of a mirror and honestly assess the contribution that fat is making to your body’s composition. It’s not hard to see.