Ever woken up to an incriminating stain on your bed sheets caused by uncontrollable bowel movements? The Food and Drug Administration (FDA) may have just redefined “wet dream,” only there’s nothing a cold shower can do for you this time.
On February 8, 2007 the Associated Press reported that the FDA had approved Alli, a fat-blocking diet pill, to be sold over-the-counter (OTC). Weight-loss pills haven’t been in short supply, but the FDA insists this drug is different. Even in advertising, it’s not a “diet supplement” but a “weight loss partner.” The pill is set to hit pharmacy shelves this summer.
Alli, pronounced “ally,” is being marketed by GlaxoSmithKline Consumer Healthcare, which, according to their website, composes seven percent of the world’s pharmaceutical market, supplies one quarter of the world’s vaccines, and spends $562,000 an hour developing new medications. Alli should cost around 60 cents a dose and it is estimated that five to six million Americans will purchase it each year, as reported by the Boston Globe. Alli is the first FDA approved OTC weight-loss pill, and is a lower dose version of Xenical, a prescription weight-loss pill that’s been available in the U.S. since 1999.
For years, companies have been advertising diet pills as a cure-all for obesity, claiming they have the magic pill to solve all of our weight loss problems. None of these “miracles in a bottle” have been FDA approved though, leading the observant consumer to wonder about the safety of his or her health when taking these diet supplements—as well they should.
Dollar Bills and Diet Pills
Diet pills compose an industry with a net worth of $18 billion, but have recently come under fire for false advertising. Companies toting their “all-natural,” and “eat what you love and still lose weight” diet supplements are slowly but surely being forced to pay for their exaggerations. On February 1, 2007 the Federal Trade Commission (FTC) fined four diet pill companies a total of $25 million for false advertising. The pills included Xenadrine EFX, CortiSlim, One-A-Day WeightSmart, and TrimSpa. FTC investigation showed that individuals taking placebo pills lost more weight than those on Xenadrine, and that people in before-and-after advertisements used the pills with scrupulous diet and exercise programs.
Victoria Adams, a junior first-year pharmacy student, is wary of current OTC diet pills. She’s seen the commercials and admits the thought of taking diet pills has crossed her mind, “but I’ve read articles about how they increase your blood pressure and can be very dangerous,” she says. Adams also questions the effectiveness of these pills, stating she has known people who have taken them and that they didn’t experience “anything very substantial in the weight loss department.”
The FTC may have brought the problems with these pills to light just in time. In the past five years, as the desperation for the “perfect body” has risen, OTC diet pills have been linked to serious health problems such as liver failure and, in some cases, even death. Is Alli different?
The New Pill on the Block
The way Alli works is relatively simple. When you take Alli capsules with a meal containing fat calories, Alli attaches to the natural enzymes in your body that break down fat. It prohibits these enzymes from doing their job and the undigested fat is not absorbed, it’s excreted. Since your body absorbs a quarter as much fat every time you eat a meal, with a low-fat diet and exercise plan Alli can help you lose 50 percent more weight than dieting on your own, according to the GlaxoSmithKline website. This seems acceptable to Jamie Lewis, a sophomore pre-pharmacy student, who says she has more confidence in an approved diet product because “the effects have been tested, and with the FDA studies there’s probably more legitimate information available to potential consumers.”
FDA director of nonprescription products, Dr. Charles Ganley, stressed to the Associated Press that Alli is intended as a weight-loss program, not a quick fix. It only works if you work. In addition to taking the pill, consumers are urged to exercise regularly as well as maintain a low-fat diet. The less fat you eat the higher percentage of it Alli can break down, forcing your body to rely on fat stores and ultimately causing weight-loss.
Leaky Pipes?
As with any medication, Alli has side effects, which Alli marketers call “treatment effects.” These include gastrointestinal side effects such as “gas with oily spotting, loose stools, and more frequent stools that could be hard to control.” As Carla Wolper, a registered dietician for the Obesity Research Center at St. Luke’s Hospital in New York City, told ABC News, “If there is too much fat in the digestive tract there are several possibilities, all unpleasant. One is a slow and subtle leakage of oil from the rectum onto underwear and clothing.” It doesn’t sound pleasant, but the pill’s maker says research shows that side effects can be limited and almost eliminated by sticking to a low-fat diet.
GlaxoSmithKline hopes to help consumers in their journey to eliminate side effects by offering an innovative support program that is available online 24 hours a day. Called “My Alli Plan,” the online system creates a customized plan of action with meal planning, menus, shopping lists, tips on managing hunger, and contacts with other Alli users to help each individual person make the lifestyle changes necessary for success with Alli. Alli is supposed to be just what the name states, an ally in your journey towards a healthier body and lifestyle. Janice Cochran, UB Dietician and Nutritionist for Wellness Education Services, thinks that this support system is the most important aspect of Alli, though she urges that people “change their lifestyle as much as possible” before committing to something as serious as a pill.
To Medicate or Not to Medicate?
Alli could provide hope to the obese who need a little extra “push” in addition to diet and exercise, and only the obese should really use it. Prescription diet pills are only prescribed to those whose body mass index is over 30, and experts caution OTC consumers to use this as a benchmark. Alli is not a casual undertaking; it’s only for those who need to lose weight for medical and health reasons. It’s not for the extra five to ten pounds you put on over break. In fact, it might not even be the best option for the people it’s designed for.
The Los Angeles Times recently reported that studies have shown that once the consumer stops using Alli, they regained much of the weight that had been initially lost. Then don’t stop taking the pill, right? Wrong. Alli is not meant for long-term use, as no studies have been done on the possible effects.
In light of this, Adams voices some concern about the approval of Alli. “The problem is that some FDA approvals can be rushed,” she says, citing the new HPV vaccine as an example, but continues, “I would rather take something that had FDA approval than something advertised on TV because you don’t really know their testing methods…the variables are too great and the drug could be dangerous. I’d recommend the gym.”
This is just one reason why not everyone is excited about this new pill. Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group, says that FDA approval of this OTC drug is extremely irresponsible. Wolfe told the Associated Press that he wants both the OTC and prescription versions withdrawn. “At a time when colon cancer is a leading cause of death and disease in the United States, the FDA’s decision to approve, for over-the-counter use, a diet drug that clearly causes precancerous lesions of the colon is the height of recklessness and shows a profound lack of concern for the public’s health,” he says.
Wolfe isn’t the only expert displeased with the FDA’s decision. Dr. David L. Katz, Director of the Prevention Research Center of Yale University School of Medicine says, “while this drug is of limited utility for weight loss, it has clear potential for abuse by teens striving for thinness. I worry about use by those with eating disorders. Fortunately, the side effects will limit the extent of this hazard, as anal leakage is not likely to be too socially acceptable among image-conscious teens, or anyone else for that matter.” Many other doctors are stressing the importance of not only using Alli correctly but also taking a multivitamin with it, as Alli will block the fat-soluble vitamins A, D, E, and K from being absorbed into the body.
Consumer Responsibility and a Last Resort
Because of the side effects, the health risks, and the responsibility that comes with Alli, Cochran points out that these drugs fall under the “buyer beware” category. She emphasizes changing your lifestyle first and using these drugs only as a “last resort,” as there have been no long-term studies on their effects. Given the drug’s side effects, Cochran says that Alli is “definitely negative reinforcement” for a lifestyle change. “You can’t eat a double order of wings and then take this pill,” she says. “There is no quick fix—the day-in and day-out is a big factor in obesity,” Cochran advises that finding a physical activity you love, taking the stairs, cleaning your house, and finding healthy foods you love can have the same effect and more health benefits than a diet pill.
FDA representatives were unavailable to comment on the decision to make Alli over-the-counter. GlaxoSmithKline directed all inquiries to their web site.
Are You the “Right Consumer?”
Alli is scheduled to hit mainstream advertising as early as mid-April, and is going to target what GlaxoSmithKline calls “the right consumer,” as Alli requires a proactive mindset and a lifestyle change. American consumers already spend $23 billion on weight-loss products such as pills, shakes, and prepared meals, but the obesity epidemic is not getting any better. Steven Burton, Vice President for GlaxoSmithKline’s weight control division has said, “given the size of the problem we have, Alli could be a significant commercial and public health success story.”
The point still remains that Alli does have its risks, and it’s important that it’s used correctly and as directed. It’s not a miracle drug or a magic pill, it’s meant to help people who need to lose weight to do so more effectively, and to enhance the effects of their diet and exercise efforts. As Dr. Alastair Woods, who served on the FDA advisory panel that passed this drug, says, “I don’t think consumers should view this as a crutch to avoid diet and exercise.”
Alli is about weighing your options. Taking it could mean a complete lifestyle makeover, and the risk of unpleasant side effects that could come into play at an inopportune moment. Anal leakage vs. a few extra pounds: what would you choose?
