I know "safety" is a key concern for people before they put anything into their body, whether it's food or a pill. That's why I find it interesting when I'm asked how alli can possibly be the only FDA-approved weight loss aid.

I get asked questions like "there are so many products available in the weight loss section of stores and/or online - how can only one be FDA-approved?" The answer is that getting FDA approval for a new over-the-counter drug is a rigorous process where studies of safety and effectiveness are carefully scrutinized. Let me give you a little background.

To gain FDA approval, OTC medicines need to prove safety and effectiveness before they can be sold. When we applied for over-the-counter status for orlistat, under the name alli, we relied on the scientific knowledge gained from over 100 clinical trials, 30,000 people who had participated in clinical trials, and 28 million prescriptions written for it around the world.

By contrast, guess how many clinical trials the maker of a supplement or herbal weight loss pill needs to submit to the FDA before it's sold "over-the-counter"? None.  They may have them, but they aren't required to share them.

Most people incorrectly believe that dietary and weight loss supplements are FDA approved

Millions of Americans are using dietary and weight loss supplements. In fact, according to our study conducted in 2005, one-third of respondents who have tried to lose weight report having used dietary supplements. And half the survey respondents mistakenly believed these supplements are reviewed and approved by the FDA for their safety and efficacy.

That surprising misconception was reported in a large survey conducted by the University of Connecticut (and funded by GSK). A key finding (download PDF of study abstract):

• Over 50% of those surveyed mistakenly believe the FDA approves weight loss supplements for safety and almost 50% believe the FDA reviews them for effectiveness.

It's my hunch that this kind of confusion about weight loss supplements is fueling Americans' use of unproven and potentially unsafe options that aren't approved by the FDA.

How do we change misconceptions about herbal weight loss supplements?

• How do we correct the misconceptions that people hold about the differences between weight loss supplements and weight loss medicines? 

I'd really like to hear your thoughts.

P.S.

To be "over-the-counter" means you don't need a prescription to buy something from a grocery store or pharmacy.  Vitamins, paper towels, weight loss supplements - they're all sold "over-the-counter." But to be an OTC (also stands for over-the-counter, are we confused yet?) medicine, a product needs FDA approval and proof of safety and effectiveness before it can be purchased by consumers "off-the-shelf."

It's a legitimate question. Is alli really needed? If eating low-fat (and fewer calories) and exercising more is the best route to weight loss, then why, really, do you need a pill like alli to help you along?

I'm hearing this question asked in numerous ways, both online and off. I heard it asked in a focus group last week. A doctor blogs about it here.

Here's my answer: If you're going to make a serious, extended effort to cut calories and fat, and to get more physically active, then WHY WOULDN'T YOU add alli? To put it another way, why wouldn't you go for a 50% better return on your weight loss effort?

If you're buying 10 gallons of gasoline, would you turn down a free coupon for an extra five gallons?

If you think about how alli works (it blocks about 25% of the fat in your meal, helping you lose 50% more weight), then not taking alli is like turning down a coupon for five extra gallons when you're already paying for ten gallons of gasoline. Or turning down the 50% more free toothpaste in that bonus tube. Obviously, using alli is not as simple as brushing your teeth or buying gasoline. You have to read the label to make sure alli is right for you. But, the point is still the same. In simplest medical terms, alli helps enhance the calorie deficit that is necessary to lose weight. 

I can tell you that I appreciated the extra help when I used orlistat (the active ingredient in alli) to lose 60 pounds over three years (I've kept it off).

By the way, here's a useful resource on Revolution Health that intelligently offers pros and cons about using alli. And not to sound like a commercial but I have to say it: more about whether alli is right for you on myalli.com (safety information and FAQs).

And if you've got a better analogy for "why use a pill" than gasoline coupons or toothpaste, let me know.

Amidst lots of suggestions on the alli discussion board about what Web sites are "helpful/fun/motivating to use as we all lose weight" I found a reference to My Virtual Model. This online application has been around for awhile but it's really taken off recently.

Major sites such as Lands End, Sears and Marie Claire (see example at left) are incorporating mvm.com into their online stores so you can "try before you buy."

So how does this relate to alli? The technology can help you visualize your progress and goals. Plus, it's a fun tool.

Start by setting a realistic weight loss goal. One tool you can use to help you do this is a BMI calculator. If you are using alli, check out the tools in your myalliplan membership and the information available in the alli packaging. 

Once your goal is set, you can choose an online retailer here. Then set up a "virtual model" and change it as you progress. Or, if you want to visualize your "before" / "after", you can create two different "virtual models" of yourself using two different login names and passwords (be sure to jot them down).

Cool, huh?!

P.S. If you want dozens of other suggestions for useful weight loss sites, visit the alli message board here. Having realistic goals is important for any weight loss attempt - modest reductions achieved gradually. 

If we're going to make progress in helping millions of people lose weight, isn't it about time that the news media, providers of weight loss programs, and others (yes, that might be a pharmaceutical company) influence the public to adopt more realistic expectations about what makes weight loss meaningful?

Number of pounds lost should not be the only yardstick of success

Medical science has proven that even a modest amount of weight loss is beneficial if you're overweight. Losing more, like 5% of your weight, leads to significant improvements in your health. That's why the government requires new weight loss drugs to meet or beat this standard. 

If even modest weight loss is beneficial, why do we expect so much when we begin a diet?

When we've asked people "how much would you like to lose", they give answers that reflect their aspirations versus what they think is realistic. I've sat through dozens of focus groups and have seen this first hand. And I suspect that when dieters fall short of unrealistic goals, they have even higher expectations the next time - creating a vicious cycle.

In fact, the vicious cycle does exist. A study [links to PDF] that we conducted with the University of Connecticut found that people distinguish between "ideal" and "realistic" weight loss.