Junkfood Science: The big sendoff

May 25, 2007

The big sendoff

Alli, GlaxoSmithKline’s new diet pill, won’t be available for weeks yet, but the next phase of the guerilla marketing is in full force and deserves one last reality check. No doubt, the last installment of this ongoing story will come laterwhen the after-market side effects become widespread.

For new readers, here’s a quick overview of the saga to date. At Junkfood Science, we’ve looked at the $100 million that GlaxoSmithKline paid Roche for the U.S. rights to Xenical (orlistat), and its petition to the FDA to market an over-the-counter version, given the cute name “Alli,” anticipating annual sales of $1.5 to $3.9 billion. Along with this investment, began an intense guerilla marketing campaign, which included creating a pseudo-professional organization and inundating the media with stories about the ineffectiveness and dangers of unregulated weight loss dietary supplements that will compete with their new “FDA-approved” OTC diet pill. Talk show hosts, newscasters and newspaper reporters fell into lockstep and took the role of marketing disguised as news. The company also sponsored a PBS documentary” — “Fat: What no one is telling you” — to convince Americans of the horrors of obesity, fat people’s “issues” with overeating, and the futility of dieting in today’s obesogenic environment without help.

Several weeks ago, one million copies of their diet book went on sale at $5.99 a pop, with 3.5 million starter kits ready to hit drug store shelves in mid-June. But television commercials are already saturating airtime, store displays are up, direct mailings and print ads are filling our mailboxes, and online ads are everywhere. Earlier this week, with great media fanfare they opened an exhibit in New York City and introduced their interactive website. Launching this diet pill has been the largest investment made in any over-the-counter brand in the past decade, said Steve Burton, a company vice president. This year’s marketing budget alone is $150 million and seven agencies have been tasked. This may sound like a lot, but it’s a small price given the millions of Americans they anticipate will be willing to pay $2 a day, $720 a year....

What will consumers get in return?

Even the company is downplaying any claims. They’re telling people it works only if they work, too. According to their website:

It won’t be easy, nothing worth it ever is. But greater weight loss is possible. 50% more than with dieting alone....if you have the will, we have the power™.

Weight loss is possible, but the reality of what people can hope to lose is considerably less than “50% more than dieting alone” might lead people to think. In clinical trials, those taking Alli-strength Orlistat along with dieting and exercise for a full year, lost an average of under 3 pounds more than those who were dieting and exercise alone. After 2 years, about 24% of the dieters and exercisers had maintained a weight loss, compared to 34% of those taking the pill. No longer studies are offered, which, like all weight loss interventions, would no doubt show the weight gain projectory to continue, even those still restricting their calories.

Should you stop popping the pill, too, that weight will pop right back on.

So 3 extra pounds lost after two years of dieting and exercising and spending about $1,440.00 for Alli — that must be the “will” they’re talking about.

Oh, but this isn’t just a diet pill, there’s also a diet book. “Are You Losing It?” offers their “keys to successful weight loss,” which includes all of those oldies dieters have tried and failed with for the past century: set small goals, eat the “right” foods and a “healthy diet you can live with for life;” choose foods low in fat, reduce calories and portion sizes; keep a food diary; and get organized so you remember to take your pill before every meal. According to the FDA document, “Alli: Read Me First” for consumers:

Under the Alli plan, a severely restrictive low-fat diet is mandatory and it has ways of making you comply. Their diet book has an extra value-added bit of advice: If you eat more than 15 grams of fat, expect some “unpleasant effects.” Their book recommends that people wear dark clothing and start the program when they have a few days off work, or to bring an extra pair of pants to the office.

These significant side effects have sparked a flurry of internet jokes about “Alli-oops moments.” [Photo as seen on Pharma Gossip:]

Xenical users have learned about these side effects the hard way. They are so unpleasant, few users continue to take it for very long. Here’s what one healthcare practitioner wrote by way of caution for those who might be tempted to take Alli, as well as for the rest of us:

HOWEVER, and this is VERY important...you will LEAK orange foul-smelling oil from your tushy if you eat fatty foods! It will not clean with toilet paper, it will stain the toilet bowl until scrubbed with bleach, and it will leak THROUGH your pants uncontrollably, also staining your clothes (it is VERY hard to get out, even with bleach). This will happen only once to convince you to decrease your fat intake..lol. No fast food on this medicine, no greasy foods, no pizza especially. I don't know why they don't warn people about this. I am an ARNP who prescribed it to many patients, but I gave them the warning to be careful. Carry baby wipes, and an extra set of pants!! At least until you know how it will affect you. Sorry, but somebody needs to warn the public. I will be afraid to sit on a cloth seat (think theater) anywhere in public when this comes out! The leaking stain is 99% permanent (smell too!). Well good luck all dieters..and don't say I didn't warn you, lol.

According to Dr. Susan Norris, M.D., of the Centers for Disease Control and Prevention, despite unimpressive weight losses, “gastrointestinal adverse effects (explosive diarrhea, fecal incontinence, abdominal cramping, anal leakage and oily discharge) were common.” Smelly, embarrassing accidents aren’t the main concerns about this drug among medical professionals, however. As we’ve reviewed, the clinical evidence for this, like all the popular diet drugs, is short-term and shows modest effectiveness and high drop-out rates. More importantly, it offers no clinical support for long-term benefits for actual health outcomes, such as cardiovascular disease or deaths. No diet pill to date has been able to demonstrate that.

While the public is focused on the weight loss, such as it is, the significance of its primary side effect is underappreciated. It reduces the absorption of fats — which are critical for health — and also fat-soluble vitamins (A, D, E and K) and beta-carotene. Twelve percent of Xenical users become vitamin D deficient within 2 years, and vitamin E and beta-carotene deficiencies have been documented in 6 percent of those taking it, according to the company's literature. If millions of Americans begin taking this pill, the numbers of those with vitamin deficiencies are expected to grow.

Young people still growing, pregnant women, the elderly, and those with gastrointestinal and absorption problems are of special concern. Dietary guidelines, for example, recommend teenage boys get 100 grams of fat a day and girls around 73 grams, significantly more than is possible on Alli. While it’s supposed to be for adults, many healthcare professionals are concerned that the readily-available OTC pills will be abused by teens and eating disorder-prone young people who already don’t hesitate to resort to laxatives.

And while vitamin supplements are recommended by GlaxoSmithKline, fat-soluble vitamin supplements are of limited value on low-fat diets. Vitamin A is important for growth, healthy bones and teeth, reproduction, vision, and healthy skin and mucous membranes. Vitamin D is critical for helping maintain bones and teeth, muscular strength, and more. Vitamin K is essential for normal blood clotting and bone health. Other concerns that have been raised about Alli include possible roles in kidney stones, hepatitis and precancerous changes in the colon.

Health, of course, is not the real reason many people will try any weight loss scheme, and the Alli campaign barely mentions health. It’s simple, however, to give consumers the perception of scientific support by letting health professionals do the marketing. Last month, GlaxoSmithKline announced their partnership with the American Dietetic Association, a fellow member of the American Obesity Association, the lobbying organization for obesity-related interests. According to the ADA press release, it’s part of their sponsorship program that provides corporate sponsors a national platform through the ADA, which has “prominent access to key influencers, thought leaders and decision makers in the food and nutrition marketplace.”

Mr. Burton was cited, saying that they would be working towards their common goals “through these public and professional awareness campaigns.” So they now have the 67,000 registered dietitian members helping to market Alli’s “healthy eating” weight loss plan. The ADA, if you’re unfamiliar with this group, is the country’s largest trade and lobbying organization for nutrition professionals and says it is committed to five issues: “obesity, especially childhood obesity; healthy aging; creating a safe sustainable food supply; nutrigenics and nutrigenomics; and integrative medicine, including supplements and alternative medicine.”

GlaxoSmithKline adopted a clever marketing tactic: “honesty.” At the New York City press event, Mr. Burton said: “Alli breaks through the clutter with straight talk, an honest voice, saying that losing weight is hard work.” The company says it doesn’t want people to have “ridiculously high” hopes and are setting themselves apart from fad diets by making it part of a “healthy lifestyle.” According to their website “You don’t just try Alli — you commit to it.” One can almost imagine the Boardroom meetings scheming how to get around the facts of its less than stellar effectiveness. P.T. Barnum was no doubt heavily called upon.

As we’ve looked at here, the Federal Trade Commission recently released a report on deceptive weight loss advertising, which identified seven bogus weight-loss claims. Products claiming to cause any substantial weight loss by blocking the absorption of fat or calories was top on their list of fraudulent claims. They said the biological facts do not support even the possibility of fat-blockers doing anything but contributing to “really modest” caloric loss. In fact, fat blocking is such a scam, the FTC and the Competition Bureau of Canada used it in their teaser site about bogus weight loss claims — called FatFoe — to help consumers spot fake diet products that “almost always signal a diet rip off.”

But GlaxoSmithKline has ingeniously planned ahead. By telling consumers up front that “it won’t work unless they do,” no one will be able to blame the pill when it fails — it will be the dieters’ fault for failing to work hard enough and follow a “healthy lifestyle.”

© 2007 Sandy Szwarc

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