"Users who consume too much fat while on the drug can expect a bowel-lapalooza of gastrointestinal side-effects."

"Have you tried dieting, exercise and support groups, but found they never seem to work? Did you lose weight only to quickly gain it back?" If this quote sounds like an ad for a prescription weight-loss drug, that's because it is. It comes directly from xenical.com. Xenical is the brand name for orlistat, a popular weight-loss medication known as a fat-blocker and marketed by drug company, Roche.

The Associated Press reported last week that the FDA appears ready to approve an over the counter version of orlistat marketed by GlaxoSmithKline and sold under the brand name, Alli. Following the lead of Australia and New Zealand, availability in the U.S. may come as soon as the latter half of 2006. Given the desperation of millions of overweight Americans and the tenacity of the drug industry, Alli has all the makings of a blockbuster. In short, get ready for the Viagra of weight loss.

Viagra Redux
In the run-up to the availability of Viagra, expectations were high. American men diagnosed with 'erectile dysfunction,' were seduced by the titillating promises of the new wonder drug. News reports practically giggled and winked with barely concealed salaciousness designed to stiffen consumer demand for Viagra.

When Viagra hit the market, the truth hit the fan. A careful read of the small print revealed that Viagra, for all its effect on male reproductive hardware, did not deliver the standing ovation many expected. Users discovered that those little blue pills could not create love where none existed or turn a looser into a ladies man. This was perhaps especially true for men who really did suffer from poor health, but there was another, unofficial, market segment where Viagra took off. Inspired by none other than Hugh Hefner, many enterprising lads, sexually healthy and fully functioning, found Viagra to be just what the doctor or in some cases, their friends, ordered.

This same type of off-market use is very likely the path that Alli will take. Given projected sales of 1.5 billion, one wonders if the execs at GlaxoSmithKline are counting on just that.

The last miracle weight-loss drug embraced by consumers was Fen-phen. It really was something of a sensation until users determined that valvular heart disease was too high a price to pay, even for weight loss. Fen-phen was a fiscal and marketing disaster for drug company, Wyeth and a human tragedy for users. But that was ten years ago and drug companies realize that a TV Nation like the U.S. with our short attention spans and even shorter memories is primed for another 'miracle.'

Willpower in a bottle: The skinny on orlistat
Orlistat is a lipase inhibitor, commonly referred to as a fat-blocker, but practically speaking, it functions more like a fat-filter that allows some fat to be metabolized while blocking about one-third of incoming dietary fat. The unabsorbed fat makes a beeline directly to the rear exit of your digestive system where it gets excreted, sometimes involuntarily. Before fat malabsorbtion was transformed into a 'healthy benefit,' it traditionally served as an indicator of an unhealthy body. Chronic pancreatitis and cystic fibrosis are just two of the diseases marked by this disorder.

Inhibiting fat is not for the faint-hearted. In fact, it can get ugly. Users who consume too much fat while on the drug can expect a bowel-lapalooza of gastrointestinal side-effects. These may include flatulence, uncontrollable diarrhea, oily discharge, orange feces and for the ladies, the pharmacologically induced equivalent of "Girl Interrupted," an irregular menstrual period. This is bad news for careless dieters, but a growth opportunity for investors in the incontinence industry.

As socially awkward as these afflictions may be, a more serious side effect is malabsorbtion of fat-soluble vitamins A, D, E and beta-carotene. These vitamins contribute to healthy skin, bones and teeth, build resistance to infections, protect cell membranes and are a source of antioxidants. They're found in foods like liver and other organ meats, milk, cheese, butter and eggs and fish oil. The Standard American Diet (S.A.D.) is woefully deficient in these nutrients.

These life-sustaining vitamins are found in the very foods that dieters are warned not to eat, so along with a recommended low-fat diet that excludes most of these foods and their nutrients, orlistat ensures that the body is further starved by inhibiting dietary fat absorption. As a counter to this problem, users are advised to take a daily multivitamin while on orlistat. The irony in warning dieters to avoid foods that contain the same nutrients they're advised to take in pill form is painfully clear. Regrettably, in a culture that increasingly views prescription drugs as a new food group, nutritional irony has become the norm.

How much weight can the typical person expect to lose?
Data from clinical trials with Xenical can be found at their web site. The average amount of weight loss over five trials is said to be 13.4 pounds. Knowing the average can be useful for interpreting some data, but when it comes to weight loss, people want to know one thing: How much weight can I (the typical person) expect to lose? It's very likely that in the studies, some people lost a lot of weight while others lost none. Which is more likely to occur for the typical person? Averaging doesn't answer that question. Instead you need to know the median or typical amount of weight lost per study.

That said, 13.4 pounds for one year of dieting is nothing to crow about. Xenical, like every other diet drug, has typically delivered underwhelming results. This is because treatment with Xenical amounts to little more than following a low-fat diet, albeit a low-fat diet that carries with it the threat of extreme diarrhea. The Xenical web site links to the American Heart Association as a source for healthy eating plans. The AHA cheerfully spouts conventional low-fat dietary advice to cut calories, noting that "losing one to two pounds per week is a good rate of loss." This contradicts the efficacy studies with Xenical which prove that, for most people, even with the aid of prescription drugs in a supervised clinical trial, losing one to two pounds per week is pure fantasy. To add fat to the fire, orlistat is a crutch drug, meaning users who go off the drug can expect to regain much of their weight.

Diagnosis
Alli, at 60mg will be half as potent as prescription drug Xenical. This suggests that users can expect to see even more dismal results from Alli. At a price point between $12.00 to $25.00 dollars per week (according to the AP) or $312.00 to $659.00 for a six month supply, one has to wonder whether the investment is worth it. Add nutrient malabsorbtion, the agony of dieting, the risk of soiling your pants in public and the reality of boomerang weight-gain and any nascent value this drug may have had disappears.

Despite the expected shortcomings of Alli, millions in advertising dollars will ensure its profitability, especially among those people who least need to lose weight. This is the Viagra effect where reasonably healthy people who just want to lose a few pounds will probably make this most recent version of the magic pill, a smashing success.

In the final analysis, there's nothing special about orlistat. It has no exceptional properties beyond its capacity to disrupt the body's ability to metabolize food. In that sense, it is nothing more than a behavior modification drug, a punishment pill, designed to force slavish adherence to the flawed dietary advice of the past 30 years. In the absence of real information about proper nutrition, the only changes most overweight consumers are likely to see as a result of Alli is a decrease in the girth of their wallets and an increase in the amount of soiled underwear in the nation's landfills.

Eat real food and read, think and learn.

SOURCES:
Xenical.com
Medline Plus
American Heart Association
Wikipedia
Associated Press: Drug Company Eyes OTC Sale of Fat-Blocker