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Bitter Pill Awards 2007: The "With Allies Like This, Who Needs Enemas? Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter
Bitter Pill Awards 2007
The ‘With Allies Like This, Who Needs Enemas?’Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter
Winner: GlaxoSmithKline, for the sale and marketing of alli (orlistat)
A drug company releases a new Over-the-Counter weight loss drug with a marketing campaign that emphasizes “there are no shortcuts” and “there are no miracle diets.” What could be wrong with this? In fact, quite a bit.
GlaxoSmithKline has been doing advance marketing and ramping up for months for the release of alli (orlistat) [pronounced AL-eye], “the only FDA approved, over-the-counter weight loss product.” This advance marketing has included the release of a book, “Are you Losing It?” that discusses the importance of a low-fat, low-calorie diet and exercise. With all the emphasis on “no quick fixes” and changes in lifestyle, the campaign looks on the surface like a refreshing change from the usual pharmaceutical advertising.
But beneath the surface and beyond the pre-marketing hype lies a drug whose benefits are questionable, whose side effects are potentially dangerous, and whose potential for abuse remains unclear. Making it Over-the-Counter eliminates any supervision by a doctor. Anyone can walk into a pharmacy and buy this drug, including teenagers and people with eating disorders.
alli is an Over-the-Counter (OTC) version of orlistat, which has been available for several years by prescription as Xenical. alli is a half-strength version (60 mg) of Xenical (120 mg), and will be available without a prescription, and thus without a doctor’s approval. alli is the latest in a series of drugs to change from being available only by prescription to being available over-the-counter (known in the industry as a “Rx-to-OTC switch”). Rx-to-OTC switches have been used in the past few years by drug companies in an effort to increase sales or compete against generic versions of the prescription version of the drug. The switch of orlistat from prescription-only to OTC appears to be an effort to boost the drug’s lackluster sales, which decreased 57% from 2000 to 2005, particularly with new competing prescription drugs for weight loss on the horizon (especially sanofi aventis’ long-anticipated Acomplia).
Switching a drug from prescription-only to OTC raises some potentially serious questions. Making a drug available OTC completely removes a doctor from the decision whether or not to take a drug. Any consumer can walk into a pharmacy and purchase an OTC drug. For drugs that treat serious or complicated conditions, it is a bad idea to make drugs that treat those conditions OTC. Generally, OTC drugs treat short-term symptoms rather than long-term conditions. These are usually symptoms that most consumers can easily self-diagnose (headaches, heartburn, allergies), and that they are able to tell when they have gotten relief from them. Being overweight or obese is not a simple “symptom” like a headache or muscle pain but is a complex condition with serious effects on all other aspects of a person’s health. (Being obese or seriously overweight is associated with higher risks of diabetes, heart disease, high blood pressure and numerous other conditions). Treating obesity and even more moderate weight loss is a complicated matter.
- Side Effects: alli has a number of unpleasant and disgusting side effects associated with it, including diarrhea, oily spotting, oily stools, flatulence with discharge, and fecal urgency. The marketing book tie-in, Are you Losing It? “advises alli users to wear dark clothing and keep a change of clothes handy until they know how the drug will affect them.” [fn1]
- Vitamin Deficiencies: Since the drug blocks the absorption of fat, it can also interfere with the body’s absorption of fat-soluble vitamins, including Vitamins A, D, E and K. Although alli users are advised to take a multivitamin, there is no way to ensure that they will. Thus, alli use could lead to serious vitamin deficiencies.
- Eating Disorders: alli may be abused by people with eating disorders. Laxatives, diuretics and appetite suppressants are commonly abused by people with anorexia, bulimia and other eating disorders. As the website of Anorexia Nervosa and Related Eating Disorders, Inc., says, “By abusing laxatives and enemas, some people with eating disorders try to rush food through their bodies before the calories can be absorbed.” [fn2] Given that alli works by blocking the absorption of fat, there is a very serious risk that people with eating disorders will use – and abuse – this drug, with potentially very dangerous consequences. Whereas the unpleasant side effects might dissuade healthy consumers from using alli, such side effects are unlikely to dissuade people with eating disorders.
- Questionable Effectiveness: The effectiveness of alli is minimal. Two studies showed that patients who took orlistat for four years only lost 2.8% more weight than those who took a placebo. [fn3] Although more weight may be lost in the beginning, in these two studies much of the initial weight loss was regained over the four years on drug. The weight loss produced by orlistat only remains as long as the drug is taken. Improved diet and increased exercise can deliver weight loss that is similar to or better than what orlistat claims, without the associated risks and side effects.
- Use by Children, Teens and Non-Overweight People: Although alli is only approved for weight loss in overweight adults aged 18 and over, there is no way to guarantee that only overweight people and only people over 18 will use it. An Australian consumer group, Choice, found that pharmacists in Australia (where orlistat does not require a prescription but is kept behind the pharmacy counter) routinely gave orlistat to young women with healthy weight levels, and rarely gave instructions about how to properly use it or about the importance of changes in diet and exercise. In the U.S. , where alli will be available on the regular pharmacy store shelves, the risk of improper use is even greater.
Misuse and abuse of prescription and over-the-counter drugs by teenagers is on the rise. At a time when they are particularly concerned about their appearance and body image, many teens may be tempted to take alli, even with its disgusting side effects. They are less likely to understand the risks and side effects, and less likely to follow the included recommendations on diet and exercise. They may not tell their parents or doctors that they are taking it. The effects of vitamin deficiencies on growing teenagers are more serious than on adults who are no longer growing and developing. These risks are even greater for teenagers with eating disorders.
- Australia banned consumer advertising for orlistat, where it is already available over-the-counter, after TV ads for the drug ran during Australian Idol, a program popular particularly with young people. [fn4]
- Public Citizen’s Worstpills.org lists orlistat as a “do not use” drug. Studies of orlistat have suggested it caused an increase in aberrant crypt foci, which could be a precursor to colon cancer. Public Citizen called on the FDA to withdraw the prescription version of the drug (Xenical) from the market, and to reject GlaxoSmithKline’s application to market alli OTC, citing seven studies investigating orlistat and the development of aberrant crypt foci that Roche included in its original new drug application to the FDA for Xenical. The studies show that Roche was worried about the link between the drug and colon cancer, Public Citizen said. As Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said, “This marks the first time, to my knowledge, that the FDA has approved a drug for over-the-counter use despite knowing in advance that the drug causes either cancer or pre-cancerous lesions.” [fn5]
- Orlistat use has been associated with pancreatitis [fn6] (an inflammation of the pancreas), and may also be linked to an increased risk of gallstones. [fn7] A memo by FDA staff in April 2007 documented 37 cases of gallstones reported by patients taking Xenical, the prescription form of orlistat. Such voluntary submissions by consumers and doctors are widely considered to be significantly underreported, so the actual number could be significantly higher.
- While GlaxoSmithKline was awaiting approval of alli, it was a major corporate sponsor of a recent PBS documentary on weight loss, ironically titled “Fat: What No One is Telling You.”
Drugs for weight loss have long been regarded as a “holy grail” of the drug industry. A recent Zogby/UPI poll found that 29% of Americans said they would likely try an over-the-counter weight-loss pill. [fn8] Approximately two-thirds (66.3%) of Americans are now overweight or obese, with nearly a third (32%) obese. [fn9] The popularity of fad diets and over-the-counter and “herbal/nutritional” appetite and weight loss aids demonstrates that many people are in search of a “quick fix” for their weight problems. The FDA’s blessing on alli will convince many people that it is truly safe and effective, when serious questions remain about it.
Making alli available over-the-counter undermines the ability of doctors to counsel their patients about the importance of diet and exercise in weight loss, and to advise them about whether they should or shouldn’t use this drug. By making alli over-the-counter, GlaxoSmithKline and the FDA have made it impossible to ensure that:
- Only truly overweight patients use alli;
- Patients use it properly, understand the directions and dangers, and don’t exceed the dosage;
- Patients follow the diet and exercise recommendations;
- Patients inform their doctors and pharmacists about their use of it to avoid dangerous drug interactions; and
- Children, teenagers and people with eating disorders don’t use it.
The extensive marketing campaign that talks about the importance of diet and exercise does nothing to change any of this – consumers will be able to walk into a pharmacy, buy this drug, and take it without following any of the accompanying advice. When the drug was available only by prescription, at least doctors were able to evaluate whether the patient was likely to make these changes before deciding whether to prescribe it for them, and to oversee the patient’s use of it in regular office visits.
In short, the marketing of alli over-the-counter looks like nothing more than a calculated ploy by GlaxoSmithKline to increase profits on a drug whose sales as a prescription-only drug were steadily declining over the past few years. (Xenical sales in the U.S. were $202 million in 2000, but had dropped down to $86.6 million in 2005. ) By removing the doctor from the equation, GlaxoSmithKline opens up a whole new untapped market of consumers desperate for quick fixes for weight loss.
As numerous blockbuster prescription drugs face competition from generics and new brand-name prescription drugs in the next few years, we may see more and more attempts to switch formerly prescription-only drugs to OTC status. The FDA must limit these to drugs that provide a real benefit and that can genuinely be used safely without a physician’s supervision. Drugs that have a long and established record of safety, and that can be used appropriately without a doctor’s supervision, can and should be made available over-the-counter. But a drug like alli, with its side effects, potential for misuse, and dangers is not one of them. For all of this, PAL awards it newest Bitter Pill Award, The ‘With Allies Like This, Who Needs Enemas?’Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter, to GlaxoSmithKline for the marketing of alli.
PAL’s press release on the award can be found here.
PAL’s recent “Ask Pharmie” column, “How do drugs go from being prescription-only to being available over-the-counter?” can be found here.
The FDA documents related to alli’s approval are available here.
1. “FDA-approved diet drug to get big sendoff,” Kim Leonard, Pittsburgh Tribune-Review, 4/30/2007
2.“Laxatives and enemas: Not the way to go,” http://www.anred.com/lax.html iii. Torgerson JS, Boldrin MN, Hauptman J, Sjostrom L. Xenical in the prevention of diabetes in obese subjects (XENDOS) study. Diabetes Care 2004;27:155-161. Kelley DE, Bray GA, Pi-Sunyer FX, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes. Diabetes Care 2002;25:1033-1041.
3. “Weight-loss pill gets heavied,” Chantal Rumble, The Age, 2/13/2007,
4. “FDA Approval of Over-the-Counter Orlistat Is Reckless: Statement of Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group,” 5. Xenical Product Information label, http://www.rocheusa.com/products/xenical/pi.pdf
6.“Weight-loss drug may be linked to gallstones,” Reuters, April 10, 2007
7.“Experts question new OTC weight-loss drug,” Anthony Rotunno, United Press International, 2/13/2007
8.National Center for Health Statistics, “Overweight Prevalence,” http://www.cdc.gov/nchs/fastats/overwt.htm
9. “There's still no magic pill for weight loss,” Diedtra Henderson, Boston Globe, 2/19/2006