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GlaxoSmithKline has launched a $150 million promotion campaign for its over-the-counter (OTC) weight loss drug, Alli. But not all media coverage is up-beat about what is a lower-dose version of Roche's prescription only drug, Xenical. New York Daily News reporter Julian Kesner reports that Alli consumers "might just find themselves $50 poorer, lacking in vitamins ... and suffering a bout of diarrhea."
GlaxoSmithKline has produced a video on what it refers to as "treatment effects," which the product pack states may include "more frequent stools that may be hard to control." A consumer coalition, Prescription Access Litigation, has given GSK its 'With Allies Like This, Who Needs Enemas?' award for marketing the drug over-the-counter, where there are less controls to ensure it is used appropriately. In February this year, the Australian drug regulator revoked Roche's approval to market Xenical with direct-to-consumer advertising, as there "was insufficient public health benefit."
Alli is an Over-the-Counter (OTC) version of a previously prescription-only drug, Xenical. PAL believes that, by aggressively marketing alli and eliminating the need for a doctor’s supervision, GSK will cause this drug to be used inappropriately and even abused. PAL is particularly concerned that the drug will be used by teenagers and people with eating disorders. Since anyone can walk into a pharmacy and buy this drug, there are no controls in place to prevent this.
Alli is the most recent example of a drug to shift from requiring a doctor’s prescription to being available to anyone who walks into a pharmacy. While there are prescription drugs with long safety records that can be used Over-the-Counter by patients appropriately without a doctor’s supervision, alli is not one of them. Rather, the switch to OTC appears geared towards increasing the sales of a drug that has minimal effectiveness, disgusting and possibly dangerous side effects and uncertain risks. Prescription sales of Xenical have been steadily declining over the past 5 years, down from $202 million in 2000 to $86.6 million in 2005, according to IMS Health. A recent Zogby/UPI poll found that 29% of Americans said they would likely try an over-the-counter weight-loss pill.
“It is extremely irresponsible for GSK to sell alli as an Over-the-Counter drug,” said Alex Sugerman-Brozan, director of Prescription Access Litigation, “Anyone – including teenagers and people with eating disorders – will be able to walk into a pharmacy and buy this drug.”
Prescription Access Litigation, a national coalition of over 130 consumer advocacy organizations that criticizes Direct-to-Consumer Advertising of prescription drugs, has given out the Bitter Pill Awards: Exposing Drug Company Manipulation of Consumers (http://www.bitterpillawards.org) since 2005. The awards are intended to call attention to particularly insidious examples of irresponsible or manipulative drug advertising.
Alli works to block the absorption of fat by the body. The additional weight loss that results is quite minimal, with two studies showing that patients who took orlistat, the active ingredient of alli, for four years, only lost 2.8% more weight than patients taking a placebo. 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. A book being sold by GSK as a marketing tie-in, Are you Losing It?, advises people taking alli to wear dark clothing and keep a change of clothes handy until they know how the drug will affect them. The drug also blocks the absorption of fat-soluble vitamins, including Vitamins A, D, E and K, putting patients at risk of vitamin deficiencies. Finally, even the modest additional weight loss only remains as long as patients keep taking the drug.
GSK has done an extensive pre-sales marketing campaign, emphasizing the importance of a low-fat diet and exercise. Notwithstanding this campaign and slogans like “there are no miracle diets,” making alli Over-the-Counter ensures that such “recommendations” are nothing more than that – recommendations that millions of consumers are likely to ignore (as they already do) and take the drug anyway, with potentially harmful consequences.
“A slick marketing campaign about changing eating habits is no substitute for requiring the prescription and supervision of a doctor,” added Sugerman-Brozan, “This is not aspirin – it is a drug with serious and potentially dangerous side effects and risks, and shouldn’t be available Over-the-Counter.”
Drug companies have often sought to switch prescription drugs to Over-the-Counter in an effort to increase sales or compete against generic versions of the prescription version of the drug. When a drug has a long and established record of safety, has a low potential for abuse, and can be used appropriately by consumers without a doctor’s supervision, it can and should be made available Over-the-Counter. But alli, which meets none of these criteria, should not. For all these reasons, Prescription Access Litigation awards GlaxoSmith Kline it first Bitter Pill Award of 2007, the ‘With Allies Like This, Who Needs Enemas?’Award, for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter.
The full text of the award, including more information about alli, is available at bitterpillawards.org
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