“This preliminary study provides evidence that there are significant changes in craving, withdrawal, and affect related to smoking the first cigarette of the day, with the largest of these changes observed for craving,” Toll said. “Moreover, changes in tobacco craving in response to the first cigarette of the day may be a novel predictor of smoking relapse that should be tested in future studies.”

Toll said it is known that smokers who light up immediately after waking are more dependent on nicotine and may have more trouble quitting smoking than those who do not. Existing evidence also suggests that individuals who experience less light-headedness in response to the initial cigarette of the morning are generally heavier smokers with a longer smoking history.

What has not been studied extensively, he said, and what was examined in this study are changes in craving and mood in response to the first cigarette of the day and examining the relationship of these changes to treatment outcome.

The standard measures of dependence include the Fagerström Test for Nicotine Dependence, which asks smokers how soon after they wake up do they smoke; do they find it difficult to refrain from smoking in places where it is forbidden; which cigarette do they most hate to give up; how many cigarettes do they smoke daily; is smoking more frequent earlier in the day after waking; and do they smoke when bedridden with an illness. Other measures include time to first cigarette, carbon monoxide in exhaled air, level of cotinine, a byproduct of nicotine, in the blood, daily cigarette consumption, and number of years smoking.

Co-authors include Ty Schepis, Stephanie O’Malley, Sherry McKee, and Suchitra Krishnan-Sarin of Yale. Published in Drug and Alcohol Dependence: (May 2007). The research was supported by the National Institutes of Health.

The book named as “Are You Losing It? Lose Weight without Losing Your Mind” comprehensively elucidates all the pros and cons associated with its usage.

The main purpose of the book is to help out users while the weight reduction that is 50 percent more when compared with dieting.

In short, the book is an introduction to the drug called alli, the first OTC pill accepted by the U.S. Food and Drug Administration. The book provides all crucial information regarding the functioning of the drug, the low-calorie and low-fat diet that one should have while its usage.

]]> http://marshallrocon.wordpress.com/2008/11/13/alli-diet-book-ready-to-knock-book-shelves/feed/ 0 marshall12 http://marshallrocon.wordpress.com/2008/11/13/telling-dieters-a-pill-works-only-if-they-work-too/ http://marshallrocon.wordpress.com/2008/11/13/telling-dieters-a-pill-works-only-if-they-work-too/#comments Thu, 13 Nov 2008 11:03:58 +0000 marshall12 http://marshallrocon.wordpress.com/?p=17 ]]> FOR decades, the beauty industry was described as – or accused of – selling “hope in a jar.” Now, a marketing blitz with a budget estimated at more than $150 million in the first year will try to persuade dieters to seek hope in a pill bottle despite widespread skepticism about the grandiose promises of diet pills, plans and potions.

The campaign, being introduced in stages by seven agencies, promotes a product from GlaxoSmithKline called Alli — pronounced, not coincidentally, like “ally,” as in a helper or associate.

Alli is the first weight-loss drug to be approved by the Food and Drug Administration for sale in the United States over the counter, no prescription necessary. It works by preventing the body from absorbing some of the fat one eats.

The campaign is centered on an elaborate Web site, myalli.com. There are also television commercials, direct mailings, print advertising, books, online ads, displays in stores and information being provided to health care professionals.

Alli is a version of Xenical, a prescription weight-loss drug sold by Roche. GlaxoSmithKline acquired the American rights to Xenical in 2005 and has spent much of the time since then figuring out how to master a tricky balancing act.

On one hand, Alli ads need to persuade dieters the drug can work well for them. On the other, the ads also must make sure the target audience — primarily men and women ages 35 to 50 — does not dismiss Alli out of hand as another unworkable get-thin-quick diet scheme.

The challenge confronting GlaxoSmithKline is epitomized in a cartoon by David Sipress in the May 7 issue of The New Yorker magazine. The cartoon shows a woman watching a TV commercial as an announcer declares, “Ask your doctor if taking a pill to solve all your problems is right for you.”

“Our vision is to change the way people think about weight loss,” said Steven L. Burton, vice president for weight control at the GlaxoSmithKline consumer health care division in Pittsburgh.

“People are really fed up because they are bombarded with hyped products, fad diets, that overpromise and underdeliver,” Mr. Burton said. “Alli breaks through the clutter with straight talk, an honest voice, saying that losing weight is hard work.”

The campaign appeals to potential Alli customers to educate themselves on using the product and improving their dieting techniques as well as their eating habits.

The dedication page of a 152-page book, “Are You Losing It?”, published by GlaxoSmithKline, refers to “the most important element of successful weight loss: you.” (A second book, “The Alli Diet Plan,” includes recipes.)

The myalli.com Web site also takes a just-the-facts tone. “You don’t just try Alli — you commit to it,” one Web page declares … or is it warns? The theme of the campaign promises, “If you have the will, we have the power.”

The emphasis on education meets with approval from a diet doctor.

“They’re trying to say, ‘We want to be forthright,’ and I think that’s reasonable,” said Dr. Arthur Frank, medical director at the weight management program at George Washington University in Washington, compared with “the advertising and marketing for most weight-loss products, which tends to be inflammatory.”

“People have been burned so many times” in trying those products, Dr. Frank said, “but there’s this eternal hopefulness they might make some progress” and Alli can appeal to that.

“This is a legitimate drug, tested, evaluated, not some hokey stuff someone is promoting through some overseas Web site,” Dr. Frank said.

Still, it is “not a drug you can be passive about,” he added, because “it does obligate you, the consumer, to take an active part in the process.”

“If you do, it can work and you can see some tangible results,” Dr. Frank said. “But you have to be thoughtful about it; you can’t take this, then go to a ballgame and have a couple of hot dogs and French fries.”

The reason for the caution is that a dieter who eats too much fat while taking Alli may experience what the ads delicately refer to as “treatment effects,” which can include “loose or more frequent stools, an urgent need to go to the bathroom or gas with an oily discharge.”

Although GlaxoSmithKline is required to disclose the side effects only on Alli packages and not in the ads, Mr. Burton said, “We go out of our way to make sure people understand how to use the product with a reduced-calorie, low-fat diet.”

“To be successful, we have to sell a program, an attitude,” he said, “and part of that is making sure people have all the information they need.”

In working on GlaxoSmithKline products intended to help stop smoking, like Nicorette and Commit, Mr. Burton said, “what we’ve learned is to present a brand that’s a partner, but not a total solution.”

“We’re here to help, but we’re not the answer,” he added. “The answer is your commitment.”

The commercials and print ads are being created by the New York office of Arnold Worldwide, part of the Arnold Worldwide Partners unit of Havas, which has worked on campaigns for the GlaxoSmithKline drugs meant to help smokers quit cigarettes.

Alli’s marketing is like ads for those drugs in that the purpose is “to give people a chance to succeed by making sure they’re prepared to make changes” in their behavior and habits, said Kate Murphy, senior vice president and creative director at Arnold New York.

The campaign is aimed at “a jaded consumer,” Ms. Murphy said, who “will say to you, ‘I’ve heard it all, I’ve done it all: Weight Watchers, TrimSpa, the cabbage-soup diet.’ And even though they don’t believe the claims, they will try it anyway.”

“We felt we had to separate out people who wanted quick fixes from those who understand they had some work to do” to lose weight sensibly and safely, Ms. Murphy said, “and if the choice is Alli, to give them everything they need to succeed.”

Pfizer, which launched Chantix last summer, said it did not expect much health insurance coverage of the prescription, which costs about $3 a day, so it priced the pill below that of a package of cigarettes.

Cigarettes are expensive and can cost $8 to $10 a pack in Manhattan and some bars in Chicago, or $3 to $4 in rural America or certain areas where taxes on cigarettes are not as high, according to Pfizer and other sources.

“It’s the difference between putting money into making yourself sick or putting money into making yourself healthy,” said Terri O’Gorman, a Pfizer director of marketing.

The U.S. Food and Drug Administration said Chantix was the first new prescription aid to smoking cessation treatment to be approved in nearly a decade when the agency cleared the drug for marketing a year ago.

With more employers and health insurers pushing high-deductible health plans on consumers that require them to pay more out of pocket for drugs anyway, Pfizer is not expecting a huge boost in coverage for the pill. The New York-based drugmaker, citing government figures, said about one in four Americans with health insurance get coverage for smoking cessation treatments and programs, according to research it did before launching Chantix.

Chantix was approved to be taken for up to 12 weeks, according to its government-approved label. Upon consultation with their doctors, smokers can take Chantix for another 12 weeks if they have demonstrated they have quit, Pfizer said.

In the next stage of Pfizer’s marketing blitz for Chantix the company this summer will begin branded consumer ads for the pill. Chantix sales were $162 million in the first quarter, with the bulk of sales coming from the U.S.

Since December Pfizer has been marketing the pill with unbranded ads through its campaign dubbed “My time to quit.” The ad campaign includes a Web site ( www.mytimetoquit.com) and offers smokers a chance to calculate the amount of money they are spending on smoking. It does not, however, compare savings to the cost of the drug.

The ingredients in the True Man and Energy Max products can bring the users blood pressure down to dangerously low levels. Both products contain either a thione analog of sildenafil, the active ingredient in Viagra, or a piperadino analog of vardenafil, the active ingredient in Levitra. People who are using these drugs for erectile dysfunction (ED) should discontinue use and contact their physician immediately combining these drugs makes them extremely defective products.

Products such as Lipozene and Centrilene have similar commercials touting the same pitch: that you don’t have to change your lifestyle to see a significant weight change.

So what’s the truth? Is there evidence to back up these late night advertising claims?

Dr. Kim Edward LeBlanc, Chief of Family Medicine at LSU Health Sciences Center, said some small studies revealed there was some benefit in taking the diet pills. However, the test subjects in the study were 25-years-old, drank a lot of water and ate low calorie diets. But there’s a reason why the active ingredient in these products—konjac root—seems offer some benefit: because it’s nothing more than fiber.

“It’s very effective at expanding, so it’s going to delay the amount of emptying that the stomach has so which gives you a better chance to feel full,” said Dr. Henri Roca, Chief of Integrative Medicine at LSU Health Sciences Center.

According to Roca, fiber can even do more.

“People do tend to lose (weight), they do tend to eat less, it also can lower things like cholesterol, reduces your blood pressure, it is effective at doing that. It does seem to also be effective at reducing insulin levels, so it can help people with diabetes as well,” Roca said.

LeBlanc added that dieters do not need to count fiber calories because they’re not absorbed into the bloodstream. They remain in the intestine to aid with digestion.

So if Lipozene and Centrilene are just fiber, should anyone spend $30 a bottle to get more fiber in their diet?

“Fiber is incredibly cheap, you can buy fruit and vegetables and do just as well and they are very tasty and very healthy for you,” LeBlanc said.

It’s a basic healthful diet that’s high in complex carbohydrates, but there are some warnings before you by these products. The bulky, high fiber in the pills can also keep some important medications for diabetes, depression and cholesterol from absorbing into the bloodstream, as well essential fat soluble vitamins such as A, D, E and K. It will not help reduce the stress hormone that makes fat deposits around your waist, and there’s also a choking risk.

“It doesn’t really dissolve, it forms a gelatinous mass, so if you take a pill people have been known to choke because that pill, if it gets stuck in the esophagus, will then expand,” Roca said.

Doctors said it would be better in powder form, called konjac flour-glucomannin; in fact, some pizza companies use it in baking to add fiber. But they do add that while most us need more fiber in our diets for good health and to prevent cancer, you have to build up fiber slowly, if not you’ll get bloated, gas and stomach distention.

In the meantime, LeBlanc said it’s okay if somebody wanted to use the quick pill rather than nature’s more wholesome fiber, but only for the short term.

“If someone wants to use that to jump start their diet or their healthier regimen, I’m all for it I’m not opposed to,” LeBlanc said. “Anything that’s safe and has hardly any side effects that’ll get somebody motivated to do some good things for themselves, I’m all for it.”

Doctors said that most Americans only get 15 grams of daily fiber, not enough to promote good health and natural weight loss. American Diabetes Association recommends 25 to 50 grams of fiber per day, the American Heart Association says 25 grams is okay, and Dr. Roca advises between 35 and 36 grams of fiber.

BOSTON — A new over-the-counter weight loss drug goes on sale next week. It’s the only nonprescription diet drug approved by the FDA. It claims to help people lose 50 percent more weight than diet alone.

NewsCenter 5′s Heather Unruh reported Wednesday on the safety of the pill

“I have lost 32 pounds so far,” said Ruth Tenofsky, of Hull.

After a six-year battle to lose weight, Tenofsky is tipping the scale in the right direction, with the help of a new diet program.

“It’s exercise, eating properly and taking the pills,” said Tenofsky.

Tenofsky is taking the diet drug Xenical, only available by prescription. But next week a lower-dose version of the pill, marketed under the name Alli, will be on store shelves. It’s the nation’s first nonprescription diet drug approved by the FDA.

“It’s a safe plan and it also works,” said Dr. Caroline Apovian, the director of the Center for Nutrition and Weight Management at Boston Medical Center.

Alli is marketed for people over the age of 18. It claims to block the absorption of roughly 200 calories of fat.

“If you’re able to lose 10 pounds using diet and exercise, you’re able to lose 15 with Alli,” said Apovian.

Apovian has written “The Alli Diet Plan.” She stresses that Alli is not a magic pill. It needs to be used with a diet and exercise plan, and there are side effects. The biggest complaint: It can cause gastrointestinal problems.

“It’s how the drug works, by blocking the fat. The fat has to go somewhere and it goes in your stool,” she said.

Tenofsky hasn’t had any side effects. She understands the drug will not work on its own. She makes it a point to eat right, and get to Boston Pilates three times a week.

“I’ve got another 20 pounds,” Tenofsky said.

“I like it so much, I bought 100 shares of Pfizer,” she says. “I really think I’m going to reap from the benefits.”

Patrick hasn’t smoked since January, which may be benefit enough. But Pfizer Inc., the pharmaceutical company, ought to be paying Patrick instead of the doctor who prescribed it for her. She has enlisted 10 or 12 others to take Chantix pills.

Patrick, a social worker at Methodist Medical Center in Peoria, Ill., smoked about a half pack of cigarettes a day, on and off for 35 years. One of her recruits, nurse Barbara Kelly, smoked a pack and a half a day for 40 years. She hasn’t had a cigarette in three months.

Both women have tried nicotine patches unsuccessfully. Kelly also has tried Zyban, another prescription smoking-cessation drug. With Chantix, they say they haven’t experienced cravings, withdrawal pangs or much in the way of side effects. In fact, neither one can stomach the smell of cigarette smoke.

“You really notice the smell,” Kelly says. “To be honest, I can’t believe I leaned over sick people smelling like an ashtray. I can’t believe I did that to people.”

Chantix, the first stop-smoking drug of its kind, entered the market with a splash. Its success rates were high enough that the U.S. Food and Drug Administration put it on the fast track for approval. Television commercials came out featuring people talking about “my time to quit,” but not the product.

The timing was excellent for employees of Methodist Medical Center who smoke. In March, Peoria-area hospitals announced plans to ban smoking on their grounds by July 4 of this year – one reason it’s been easy for Patrick to convince colleagues to try the drug. But they’re not the only ones interested.

“We’ve gotten a number of calls about it,” says Linda Preckwinkle, who manages the American Lung Association’s quit-smoking line out of Springfield, Ill. The line, funded by proceeds from the state attorney general’s lawsuit against tobacco companies, provides basic stop-smoking counseling services.

But there are those who are leery about Chantix, its success rates as a stop-smoking aid and its side effects.

“There are still so many unknowns,” says John Polito of South Carolina, an ex-smoker who advocates quitting cold turkey through his Web site, whyquit.com.

“If you go back and look at the gum, the patch, Zyban, there was tremendous excitement when they first came out, too.”

Unlike Zyban – also known as the antidepressant Wellbutrin – or nicotine patches and gums, Chantix goes straight to the brain and blocks the receptors that produce physical cravings for nicotine. Soon after smokers start the initial 12-week regimen, many say they lose the desire to smoke. Like Patrick and Kelly, they say they can’t stand the taste or smell of tobacco products. A second 12-week regimen is prescribed for successful quitters to boost the drug’s effectiveness.

Doctors recommend smokers continue smoking one cigarette a day for the first week after they start taking the drug.

“It got to the point I had to force myself to smoke that last day because it tasted so horrible,” Patrick says.

In clinical trials, the most common side effects include mild nausea, headaches, vomiting and vivid dreams.

“About 3 percent of people have to stop taking the drug because of severe nausea,” says Dr. Michael Peil, a Peoria pulmonologist, “But most can get by that by taking it with food or cutting the dosage.”

Peil states up front that he’s a paid speaker for Pfizer, makers of Chantix. But he’s more measured in his responses about the drug than Patrick, who got her prescription from him.

He says he has seen success with people who haven’t been able to stop smoking using other smoking-cessation aids. But he’s also seen people who aren’t able to quit smoking the first time around.

“As with any drug, there’s going to be failures.”

Less than half – 44 percent – of Chantix users completely abstained from tobacco after three months. The percentage dropped to 22 percent after one year, according to the results of several clinical trials.

Still, those quit rates create excitement in the low-success arena of smoking cessation.

“In the past, if you got a 7 to 10 percent success rate at the end of a year, you were doing good,” Peil says.

He and Preckwinkle emphasize that Chantix is not a magic pill. It can help reduce the physical addiction to nicotine, but newly-quit smokers need additional help dealing with the psychological addiction to nicotine.

Doctors, smoking-cessation counselors, even Pfizer, recommend using Chantix or nicotine replacement therapies in combination with counseling, support groups or other resources designed to help recovering smokers change habits associated with smoking.

Peil tells patients not to consider themselves failures if they fall off the wagon.

“It can take up to 10 attempts to quit smoking successfully,” he says. Even using a Chantix pill.

Sanofi-Aventis AS has told the Food and Drug Administration it wants to sell the drug rimonabant under the brand name Zimulti. Concerns about its psychiatric effects have delayed a final FDA decision on the medication. The agency previously told the French company it would not approve the drug to help smokers quit.

A final ruling by the FDA is expected by July 27. The agency is not required to follow the advice of its outside advisers but does so most of the time.

Rimonabant blocks the same pleasure centers in the body activated when marijuana smokers get hungry. Blocking the receptors leads to patients eating less and losing weight.

The prescription drug, when used in conjunction with a modest calorie diet and physical exercise, significantly decreases body weight and waist circumference in overweight or obese patients, according to Sanofi-Aventis. In yearlong studies, patients on the drug lost roughly 14 pounds (6 1/3 kilograms). Those given dummy pills lost only about 4 pounds (1.8 kilograms). Patients regained weight when treatment was stopped after a year, the company said.

What worries FDA reviewers is that the drug’s effect on the body’s cannabinoid receptors could lead to psychiatric symptoms, including anxiety, phobias, depression and post-traumatic stress disorders.

In studies, 26 percent of patients given Zimulti reported such a symptom, compared with 14 percent of those given sham treatment. Specifically, 9 percent of those treated with the drug reported symptoms of depression, compared with 5 percent given dummy pills.

Sanofi-Aventis seeks to sell 20-milligram Zimulti tablets to the obese and to those who are overweight and have type 2 diabetes, high blood pressure or other conditions that put them at risk of cardiovascular disease.

Obesity rates have exploded in the past two decades. Today, nearly one in three American adults age 20 or older is obese, according to government data.

Generally, anyone with a body mass index, a ratio that takes into account height and weight, greater than 30 is considered obese. The overweight BMI range is 25 to 29.9. Normal is 18.5 to 24.9.

Rimonabant is sold under the brand name Acomplia in Europe.

An FDA spokeswoman said that the panels’ deliberations reached to the notion that risks associated with the drug’s usage are not really worth its benefits and thus the panel’s final response was pessimistic.

The FDA will take up a final decision over acomplia’s approval for sale in the U.S. in the late July. Traditionally, the FDA considers suggestions furnished by its advisory committee while making any approval verdict. During the voting, acomplia approval was shot down by the score of 14-0.

The report formulated by the FDA and released on Wednesday has evoked concerns over the safety of the drug, essentially about its impact on consumer’s mental fitness. Paris-based drug maker provided data for its product review last year.

During the clinical trials, the drug has shown many adverse effects on human health. The encountered side effects include depression, anxiety, sleep disorders and psychomotor agitation.

The FDA’s Division of Metabolism and Endocrine Products is also laden with many reports related to the worse effects of acomplia. According to the report, there were 4 incidents of delusional symptoms, 5 cases of aggression and 6 episodes of psychotic behavior.

Rimonabant, a generic equivalent of acomplia is approved in 37 countries and can be marketed in 18 countries, as per the estimate of Sanofi-Aventis.