Arlene Weintraub of Business Week says that "lifestyle drugs are defined loosely as products used to treat conditions that are not life-threatening." She puts alli in that category. I disagree and here's why...

First, obesity is one of the leading causes of preventable death in the U.S. Some claim it's the second leading cause of death, after smoking. Second, 65% of U.S. adults are either overweight or obese.

Given those rather surprising facts, here are two points to consider:

1. Even modest weight loss has been shown to result in meaningful improvements in health.

2. Weight loss programs like alli have been proven to make diet and exercise more effective.

One more point that we want to clarify: alli is intended for adults who are overweight and who need added help to reach their weight loss goals. They must also be comfortable with trying a gradual and healthy weight loss program.

It's not for people who are *not* overweight, and in fact, we have some controls in place that discourage underweight people from using the product. In addition, no one was underweight in our pre-launch study - which was open to any adult.

While it's still early in the launch of this new product, our latest research shows that it's being used by the people who need it most.

In fact, among over 46,000 alli buyers registering to date for the myalliplan, no one was underweight. 93% were either overweight or obese, with an average BMI of 32.

The remaining 7% were in the normal BMI range (18.5 to under 25). Reassuringly, they had weight loss goals that would keep them at a healthy weight. 

Despite news stories suggesting "skinny" people are buying alli, we see no evidence that they are.  But it is something we're on the look-out for, just in case - because skinny people don't need alli.

It's no surprise that there are videos on YouTube (see here) that make fun of alli's potential treatment effects (TEs as they're being called). We loved toilet jokes in kindergarten. And apparently a lot of folks still like them now.

Mainstream media is also fixated on alli's possible side effects. See Google news search results on "glaxosmithkline alli." I find it interesting that this is the "news hook" dominating coverage of alli. For in fact...

1. The folks who are actually using alli seem to have a positive attitude about TEs; i.e. they know they can control them.

2. Treatment effects are avoidable if you watch your diet and limit your fat to 15 grams per meal.

Anecdotal reports from the alliFirst Team members say that run-to-the-toilet episodes are manageable and rather rare. The 400 alliFirst members were recruited in April to try alli so they've been using the product for several months now. Their experience should be a useful guide for others.

(Full disclosure: I'm not currently using alli as I'm not overweight.)

Still don't believe me on TEs? Watch Stand-Up Doctor (who is not affiliated in any way with GlaxoSmithKline). He describes himself as a family physician and weight loss doctor by day and a stand-up comedian at night. He has previously prescribed Xenical, the prescription version of alli (it's twice the dose or 120 mg of Orlistat). He says on the video:

"Even at the prescription dosage although people seemed to get a little gassy and sometimes bloated and even occasionally had diarrhea, I never had a (patient) tell me they had an accident or that they couldn't make it to the bathroom... "

The crux of the alli plan is that you have to eat a sensible, low-fat, reduced-calorie diet and get a moderate amount of exercise while taking the capsules.

For those interested in following a diet program or plan, here are the pros and cons of using alli with popular diets - from the very low-fat to the low-carb, high-fat .

As the graph from the Companion Guide inside the alli package shows (click on the image above), you want to avoid diets very high in fat like the Atkins program. Why? You'll get treatment effects like loose stools and have to get to the bathroom very quickly. alli blocks 25 percent of the fat you eat so the more fat you take in, the more fat needs to come out the, er, other end.

By the same token, you want to avoid diets that are very low in fat, like Pritiken, since there's little or no fat to block. 

The good news is that there are many diet programs that work in combination with the alli program.  Commercial weight loss programs like Weight Watchers, Jenny Craig or Nutrisystems all have low-fat reduced calorie options that are compatible with alli.   

This is not an endorsement of any of these diet programs. And they haven't endorsed alli.  Just an explanation.

To say I'm excited would be an understatement. I've been working on the creation of alli, the first OTC, FDA-approved weight loss product, for over three years.

As of today you can find it on the shelf at your neighborhood pharmacy. Look for alli at participating grocery, pharmacy, and mass retailers and on-line websites. And expect to pay about $55 for the 90 count supply in the educational starter pack.

It's a clear plastic box which contains a month's worth of the capsules (60 mg orlistat capsules) as well as 7 pocket sized booklets and a funny looking blue carrying case we call the alli Shuttle. It holds a day's supply of alli and I like the way it feels. I can't stop rolling it around in my hand.

Some people say the curvy contour feels like a handshake. Fitting for a brand that's about partnership. 

You also get access to the online (free) individualized action plan at myalliplan. There you create your own micro-site to track your results and receive lessons and advice tailored to your situation, based on what you choose to share with us.

Note: The comments on this blog from the alliFirst Team are uniformly - unnervingly - passionate and positive about using the product. See here and here and here. Yup, I was a bit suspicious as you might be too. But the folks at GSK assure me the alliFirst members have not been coached on what to say. 

They're getting a good deal: a six-month supply of alli (worth about $300) as well as access to private online support communities.

Along with the chance to get up close and personal with the alli brand team. For anyone trying to lose weight, who wouldn't want to join the alliFirst Team?

I was curious how GSK chose the lucky 411 who got to try alli before it became available to the public this week. (You should be able to find alli on shelves tomorrow.)

The inside story on the alliFirst Team

Here's what I found out:

GSK asked Communispace, which runs private online communities (discussion groups), to send out email invitations to become an alliFirst member. A total of about 2000 email invites were sent out.   

463 people qualified to be alliFirst members (i.e. they were at least 15 pounds overweight and willing to commit to a low-fat diet and to an exercise program).

411 of those were selected to join the alliFirst team.

The pool of email invite recipients came from three sources:

- those who had visited QuestionEverything.com and indicated they were interested in learning more about alli

- those who answered the "are you ready?" questions affirmatively on myalli.com

- past members of Partners in Weight Loss (a GSK community for overweight women) who also said they were interested in trying alli when it became available

Typical profile of an alliFirst Team member

A typical member, the GSK folks tell me, is a white woman ages 30 - 39 who wants to lose 16 to 50 pounds. She has attended two to four years of college and her household income is between $50,000 and $100,000.

She has tried other weight loss programs in the past, is highly motivated and has agreed to the alli readiness questions.

Namely, she is willing to do the "hard work" to lose weight gradually, is committed to following a reduced-calorie, low-fat diet with an average of 15 grams of fat per meal AND...

understands that if she takes alli with a meal containing too much fat she may get treatment effects (that's GSK term for side effects) such as gas with oily spotting, loose stools and more frequent stools that may be hard to control.

Yup, these 411 alliFirst members appear to be a hardy group as well as super enthusiastic. Seems like a great marketing move on GSK's part.

You may be hearing from a select group of people who started using alli in April. We're calling them the alliFirst Team. They are 400 overweight adults - men and women - whom we recruited as eager volunteers to try the alli program.

Hundreds of clinical studies have been done on Orlistat, the active ingredient in alli - but we wanted to get some early feedback based on "the real world."  You may have seen comments about alli on other sites.  alliFirst members have set up their own online communities (on SparkPeople, for example) to share ideas and help each other. 

The alliFirst members have received many of the same educational tools that will be available this coming Friday when alli hits store shelves.  They've also received a six months supply of alli to compensate them for their advice - but their opinions are their own.

Read on for the invitation letter we sent to the alliFirst Team to come check out this blog.

Letter sent to alliFirst Team members

Dear alli First Team:

We would like to invite you to be among the first to visit our blog at alliConnect.com.  The alliConnect blog is a place to talk about weight loss with the alli brand team.  You are welcome to leave a comment, but you don't have to.

You should keep in mind that if your comment is published, it will appear on a public web page and will be seen by others.  So you should be careful about revealing too much personal information. 

However, we would like you to identify yourself as someone who is part of the alli First Team - a special group of consumers who are already using the alli weight control capsules and program.  And as always:

- express only your own opinion

- share only your own experiences; do not write about others on the team

- comment on what you know from personal experience; do not speculate or fabricate

- disclose that you have received product at no cost but that you are otherwise not compensated by GSK, the makers of alli

- be respectful and thoughtful; your comments will be read by many

We continue to value your insights, opinions, suggestions and appreciate your dedication to the alliFirst team.

Sincerely,

Karen L. Hill, Associate Brand Manager, Weight Control
GlaxoSmithKline Consumer Healthcare

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Here's my oops story... Consider it a cautionary tale. But also take heart. It wasn't that big a deal. And it only happened once. (I've even talked about it on CNBC.)

Treatment effects are common if you eat meals with too much fat. They aren't a safety concern - they won't hurt you. But they could be embarrassing if you aren't prepared to deal with them.

The rule of thumb is to limit your calories from fat to about 30% per meal, or about 15 grams of fat per meal. 

I learned this the hard way when I ate a fish sandwich and french fries from a fast food drive-through WITH TARTAR SAUCE, and a soda.  Really smart, huh? 

Good thing I was close to home so I could change my clothes.*  But you know what?  It hasn't happened since. 

Yes, I still see occasionally undigested fat floating in the toilet. But I'd rather have the fat flushed away when I go to the bathroom than have it wrap around my waist or clog my arteries. 

Studies show that about one out of every two alli users in a real world setting (real world, meaning you're on your own, versus being part of a "controlled clinical trial" where you get lots of instruction and advice) don't even get treatment effects.  Those that do should expect to experience a "signal" that alli is working to block excess fat- but very few people (something like 5%) stop using the program because of how the product works.

Over time (I've lost 60 pounds and kept it off for about three years) I've learned to make changes in the way I eat. I still enjoy steak and potatoes - but I pick filet or strips versus rib eyes, and pass on the butter.

* My oops experience happened surprisingly quickly. That's not typical. The delay between eating a high fat meal and experiencing treatment effects varies from person to person but is generally 12 hours.

I'm frequently asked "Hey, Mr. Marketing Guy, why are you being so cutesy and calling uncontrolled bowel movements 'Treatment Effects.' Can't you just be real and call them side effects?"

Well, we could, but calling them side effects is actually misleading.

Side effects vs. treatment effects

Side effects are generally unrelated to what a drug is trying to fix and often are harmful. 

For example, I take a calcium channel blocker to lower my blood pressure.  It also makes me dizzy.  But I don't take the channel blocker to get dizzy. If I wanted to get dizzy, I could chase around my 4 kids and 2 dogs. 

I take my calcium channel blocker to reduce my blood pressure and to get out of any hard work that requires me to operate heavy machinery (which my drug's label suggests I avoid).

How alli works

When you take alli, the blocked fat goes out the only exit available.  If you eat too much fat, the fat excretion is ugly.  That's how the drug works!  The exiting fat isn't a side effect, it's the actual treatment of the drug. Hence, "treatment effects." By the way, they are not harmful in any way.  You are not losing electrolytes, just fat.  You didn't need the fat anyway.

And while you are on alli, you can operate heavy machinery.  Just thought you'd like to know.

You may have heard about the book are you losing it? and wondered what it was all about.  If you've seen it, odds are you found it in places you wouldn’t expect... like your local pharmacy counter or on the shelf in the weight loss product aisle (while supplies last).

This is not a money-maker for GSK. We've pledged all of the profits from the book to help prevent childhood  obesity through programs offered by Shaping American’s Health and NAASO, the Obesity Society.

If you want to learn more about the book, go to areyoulosingit.myalli.com.  Keep in mind that the book isn’t just about alli - only 21 of the 150+ pages talk about the alli program.  But, one of the pages does include information about the alli treatment effects (page 69), as mentioned by CNBC's Mike Huckman.

New York Times reporter Stu Elliott gave us a nice write-up in his advertising column: Telling Dieters a Pill Works Only If They Work, Too. (You may need to register to read the article.)

He pretty much nails the nut of our message... alli only works if you work at it.

And he notes the complexity of the ad campaign for alli: we're working with no less than seven agencies (from print and TV advertising to direct marketing to PR to online and interactive to media buying). If I seem a little frazzled, that's probably why...

In a two-minute video segment on CNBC, pharmaceuticals reporter Mike Huckman throws the fat - literally - on the table. I.e. one of those lumps of plastic fat.

He talks about alli's educational approach to marketing and tells listeners about our new are you losing it? book on sale now.  (You'll find it in retailers like CVS, Rite Aid, Walgreens, Wal-Mart, etc.).

Of course, after interviewing me, he just can't help making fun of how alli works. Oops...

Have you ever poured over a BMI (Body Mass Index) chart trying to determine whether your weight was in the healthy range? In case you're wondering, BMI equals a person's weight in kilograms divided by height in meters squared. (BMI=kg/m2).

We found an online BMI calculator that we thought you might find useful.

Here's the original TV ad for alli. It was prompted by the fact that we've heard from so many people who are fed up with fad diets, hyped claims and "miracle pills." Yup, we've got our own YouTube channel (you can watch all our TV spots).

Shopping around for a new weight loss option usually means a trip to the store.  If you're in New York City, now it's a trip to a bank. A trip that may be worth its weight in gold - at least in terms of information.

The alli Experience, an interactive and educational exhibit, is now occupying a bank built in the 1800's. It's free and open to the public May 22 through June 10, 2007.

Thousands of visitors have toured the space at 20 Union Square in lower Manhattan. You can walk around inside to learn about alli, talk to pharmacists and registered dietitians, and decide for yourself whether alli is right for you.

Yes, you'll learn about treatment effects. You'll even get a free book. And if you're not able to visit the alli experience in person, you can get a virtual tour at myalli.com.