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Alli: The First OTC FDA Approved Weight Loss Drug

There really are so many weight loss “pills” on the market today. You can find them, unregulated by the FDA, on shelves at places such as your local CVS and GNC. Then there are weight loss “drugs,” which are regulated by the FDA and can only be prescribed by your doctor. Now there is a weight loss drug made by Glaxo-Smith Kline called Alli (said Al-eye) that is FDA approved, but will be sold as an OTC drug.

How the Alli program works:

* You take a capsule with every meal.
* You register online to gain access to an individualized action plan.
* You check in weekly through the Alli site.
* Through the action plan you learn lessons about meal planning, managing hunger, dealing with setbacks, and making the food and lifestyle changes to help you succeed.
* Access to menu’s and how to shop for low-fat meals.
* Connect with other Alli users.

Alli is not only the first FDA approved weight loss drug OTC, it is the only FDA OTC that is both a weight loss drug and a weight loss treatment plan with support. Alli is Orlistat 60mg. Xenical is a good comparison, as it is also Orlistat, except it is sold in 120mg capsules and can only be prescribed by a doctor. Orlistat works by blocking fat absorption into the body. Alli blocks 25% fat absorption when you take the pill with each meal. Blocking fat results in “treatment effects,” otherwise known as frequent trips to the restroom. Alli’s capsule and program appears to be the perfect form of Classical Conditioning. If you eat meals high in fat when taking Alli, it results in frequent treatment affects, in order to avoid this you need to lower your fat intake to 15 grams or less per meal. Of course, no one wants to experience treatment effects, so they will lower their fat intake, which in combination with Alli provides a successful weight loss. This type of conditioning can be an excellent way to rethink the way you eat and create a new behavioral eating pattern. As you take Alli and recondition the way you eat, it becomes second nature by the time you have met your weight loss goal and no longer need to take Alli. In the end, this will result in long-term weight loss maintenance because you retaught yourself how to eat the correct way.

Weight loss drugs prescribed by a doctor:

* Are monitored by your doctor, which means that the use and effects are described to you in great detail.
* It is your doctor that makes the decision if a weight loss drug is the preferred method for you to lose weight. Your doctor does this by looking at your health history, how overweight you are and if you are taking any other medications that might interfere/be affected by the addition of another drug in your system.
* There is no way to fudge your weight or BMI in the doctor’s office.
* No need for a computer.
* If you are under the required age to take the drug, the dr. finds an alternative treatment for you.
* Only so many pills are given per month to prevent abuse of the drug.
* Doesn’t teach you meal planning or offer a support program that you can have access to 24/7.

Alli:

* For persons 18 years+. How will that be enforced?
* For a person who “needs to lose weight.” A person’s idea on their need to lose weight is subjective. Anorexic’s think they need to lose weight. I don’t see anywhere on the Alli site where it gives a specific requirement for weight loss say like Meridia, where it is only for individuals who have a BMI of 30 or higher. Alli’s site does have a BMI calculator, however anyone can manipulate it and certainly no one is standing over your shoulder to ensure accuracy. So regardless of your BMI, no one will stop you at your local drug store from purchasing it.
* What if you are on other medications or have a history of diabetes, heart condition, high blood pressure, etc? It appears that responsibility is left in your hands to decide for yourself the risks involved.
* Requires access to a computer and the internet.
* There is no inhibitor from taking too many capsules or not registering/participating online, as when you are on a weight loss prescription where you have no choice but to follow dr.’s orders in order to get your next prescription.
* Alli’s site says a capsule is to be taken with each meal. However, the starter kit
shows that you take 3 capsules a day. What if the Alli user eats 6 small meals a day? Do they then take a capsule each time? Can you take too many pills in a day? How is that regulated, since you can just go right back out and purchase another bottle when you run out, unlike a prescription that is given for so many pills per day.

As you can tell, there are so many questions that go along with having an FDA approved weight loss drug as OTC.

Alli’s marketing plan:

Alli will be launching this summer, so in the months prior Glaxo-Smith Kline is trying to educate the public on their product. The Alli site is very comprehensive, although it still leaves a lot of questions unanswered, and is pretty straightforward letting consumers know that this is not a miracle pill or a quick way to lose weight. They stress the importance of being committed to the program and not to take short cuts. They also make it very clear that the active ingredient involved is you. I definitely think they are going about this the right way in terms of education and being crystal clear about what Alli can and can’t do.

What will this do to the diet industry?

I think it is very much up in the air until the product launches. If we start seeing health complications and abuse of the drug, it could very well be a downward spiral. However, if the program is proven successful, I could certainly see a lot of cross-promotion going on. We may see diet programs such as Nutrisystem or Weight Watchers incorporating Alli into their overall weight loss program. We may also see other pharmaceuticals such as Roche, the distributor of Xenical, launching their own FDA OTC to compete.

What do you think about an FDA approved weight loss drug going OTC? Do you forsee issues arise or success? How do you think this will affect the weight loss industry?

Comments (5)

Janet:

Is Alli already being sold over the counter?
Where?

Hi Janet,

Alli won't be out until this summer and I believe you will be able to find it at your local drugstore.

Vanessa:

This summer when?

Hi Vanessa, the only information the Alli site gives is that it is available this summer. However they do have a form you can complete to get updates on Alli, which I'm sure would include when it will be released. The page is here: http://www.myalli.com/Notify.aspx

Dawn:

I hope people do not abuse it. They should keep it behind the counter and distribute it like they do alcohol and cigarettes.

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