A version of this article has been picked up by a magazine, but here is the blog version.

The Fat Loss Troubleshooter: Dangers of Alli: The Truth About The New FDA Approved Diet Pill

Well the time has come, it has been many years in the making. I remember a year ago reading the studies that were coming out about this drug and counting the days before I saw it lining the shelves. Then the other day I was sitting down after dinner and saw the first commercial promoting it through Walgreen's and felt a heavy heart. It is now airborne. I say airborne and yes mean it almost in the manner of Dustin Hoffman in Outbreak where he realizes that the virus is moving through the air ducts infecting others. We have an epidemic, is it to late to stop it? I, for one, am going to try.


What is Alli?

Alli is a weight loss program that bases itself around a weight loss pill. That in itself is really nothing new. What is new is that it is the first FDA approved weight loss pill for over the counter use. I am not going to input too much of my thoughts on the FDA, I will just say that looks like that they want their cut in this over the counter market too. The active ingredient in Alli is Orlistat. How it works is actually pretty simple.

How does it work?

When you decide to take a bite of food, that food is made up of three nutrients, proteins, carbohydrates or fats. These substances all have energy or more popular known as calories. Depending on what the item of food is, depends on what it has more of what nutrient. An apple for example is largely made up carbohydrates, where an avocado is made up of mostly fat. When you digest these properties your body sorts them to where they need to go, or stores them for later use. If you have an excess quantity of energy (calories) then this is how the body gains mass from the storage of those nutrients.

Orlistat comes into play whenever you eat fats. When you eat the fat and it enters your digestive system Orlistat will attach itself to some of that fat and block it from being broken down by your body's natural enzymes. Since it can't just float around in there, your body will then pass it through your digestive system, into your intestines and eventually out through your bowels. In short, this pill turns some of your fat intake into a fiber type source. Just like when you eat fiber, your body can't break it down and digest it, so it passes through your system. This also means that the energy (calories) do not count, so the fat you eat you isn't absorbing into the body.

Off the bat it doesn't sound to bad does it? Well like anything it isn't that simple.

The Problems of Alli

First off let me state that taking the pill alone will do nothing for the fat that you already have stored. This means that if you have fat already you still have to get rid of it by using a lower caloric diet. That is what the full Alli plan is about, pill+diet program=fat loss. The diet plan is no different then all the other diet plans that are out there right now. Too low of calories and here low fat. The recommendations range from 1200-2000 calories a day depending of course if you are a man or woman. Most important though are the fat intake guidelines. You have a certain amount of fat to take in at given points and time. That isn't really anything new and not eating too many fat calories isn't going to stop you from going overboard on calories in general. Didn't we learn anything about the low fat craze? What is new or more fun even is what happens if you go past those fat guidelines. If you take into much fat you get what is known as “Treatment Effects”.

What are “Treatment Effects”?

The popular treatment effects that you may have already heard about already mostly have to do with your bowel movement. The simple and short reason is because your body cannot break down and digest fat, your body is going to put that fat on an express lane. Since fat is oil, when it gets to the final stop it is still in a liquid form. It becomes a great lubricant for the movement of stools you have stored already in the body. This could lead to leaking, wet gas, diarrhea, and a sudden event where you could at any moment “go”, without being in control. To add more fun to this, the moral of the story is, the more fat you have in your diet, the more likely this is to happen. This is actually part of their behavioral modification aspect of Alli. They teach you that if you eat too much fat, your punishment is an accident in your pants.

What about the other side effects?

Orlistat has been used for years now in a prescription capacity to treat obesity. Meaning that until now you could only get this ingredient by prescription from seeing a doctor. The good news is because Orlistat has been around already for a while I don't have to wait for my logic to tell you what scientist has already gotten a chance to test.
What they have found is quite interesting but apparently not interesting enough to reveal to the advisory board that is responsible for giving the okay to this being an over the counter product.

Neal Benowitz, a professor of medicine and biopharmaceutical sciences at the University of California, San Francisco, had this to say about the results I am going to share with you. “This was not in any of the documents that we reviewed,” he commented about the aberrant crypt foci issue. “Unless it gets reported by the manufacturer or FDA, or someone brings it up who gives testimony, we may not know about this.

So what was it that has been found out about this drug that would lead to this kind of hiding? What are the other side effects of Alli? What is the aberrant crypt foci issue?

A study done shows significant increase in the incidence of aberrant crypt foci. These crypts are widely believed to be a precursor of colon cancer. This is also not a bias study done by a competing drug company either. The National Cancer Institute has done these works and they have established a healthy link between ACF and colon cancer.

That is kind of a big problem to leave casually out of a report.

Another scary problem that could exist is the chance of breast cancer. “In the seven randomized, controlled clinical trials, there were 10 cases of breast cancer in the treated groups with only one in the control groups. The relative risk of getting breast cancer while taking Orlistat (compared to placebo) was calculated several times by both FDA and the sponsor and found to vary between 4- and 7-fold, depending on the analysis.”
That is some pretty startling results, so much so that it causes a FDA Medical Officer to take back his original approval

Let's say that this wasn't an issue or that you just don't care about the cancer aspect of Alli. Do you care about your hair, nail growth, skin aging process, good cholesterol? Then Alli may not be for you.

When you block fat from being absorbed in the body, you are blocking the valuable nutrients that fat can provide. We have already learned from study after study how valuable and important fats are for the basic needed function of the body. Since you have to take in a low fat amount (remember you don't want to have an accident) as it is and of those fats a certain quantity of that intake is going to be blocked, in a day your percentage of fat from you diet is going to be too little to provide the best of basic function for your body. The negative effects of that will wage war from things ranging from your hair and skin to your HDL levels.

To add one more insult to injury. Because you can't absorb the fat and you don't get all the calories from the fat you are taking in, you already low calorie diet, becomes even lower. Low calories diets as we have learned lead to weight re-gain, hormone dysfunction and unhappy bodies.

Does Alli's Benefits Make Up for the Risk?

As simple as I can put it, no. Give it a few years and you are going to see the local lawyer firm advertisements that go “Are you or a loved one suffering from the effects of taking the drug Orlistat?” When you see that pop up I hope you are smiling because you read this report and you decided that bowel movement diet therapy wasn't for you.

Not to mention it isn't even easy. You still can't eat well, can't eat certain foods and on top of that have to worry about running to the bathroom in embarrassment. How this program got as far as it has in the first place is beyond me. One thing is for sure; its shelf life is short, both in consumer desire and in government allowance.

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“Section 28: Gastrointestinal Tract. Genetic pathways in colorectal cancer” in Cancer Medicine 6th ed. Donald W. Kufe,. Raphael E.Pollock,; Ralph R. Weichselbaum, et al.,editors. Hamilton (Canada): BC Decker Inc; 2003.

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David Hertig. FDA Pharmacology Review of Orlistat. April 28, 1997:53.

Garcia SB, da Costa Barros LT, Turatti A. The anti-obesity agent orlistat is associated to increase in colonic preneoplastic markers in rats treated with a chemical carcinogen [dimethyl-hydrazine]. Cancer Letters 2005;December 22:; [Epub ahead of print] PubMedID: 16377080

Pretlow TP, Pretlow TG. Mutant KRAS in aberrant crypt foci (ACF): initiation of colorectal cancer? Biochimica et Biophysica Acta 2005;1756:83-96.
Bird RP. Observation and quantification of aberrant crypts in the murine colon treated with a colon carcinogen: preliminary findings. Cancer Lett. 1987 Oct 30;37(2):147-51.

Pretlow TP, Pretlow TG. Mutant KRAS in aberrant crypt foci (ACF): initiation of colorectal cancer? Biochimica et Biophysica Acta 2005;1756:83-96.
Hurlstone DP, Karajeh M, Sanders DS et al. Rectal aberrant crypt foci identified using high-magnification-chromoscopic colonoscopy: biomarkers for flat and depressed neoplasia. Am J Gastroenterol 2005;100:1283-1289.

Bird RP, Good CK. The significance of aberrant crypt foci in understanding the pathogenesis of colon cancer. Toxicology Letters 2000;112-113:395-402.
David Hertig. FDA Pharmacology Review of Orlistat. April 28, 1997:54.

Kelley DE, Bray GA, Pi-Sunyer FX, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes. Diabetes Care 2002;25:1033-1041.

Excellent find

Good Article. Why don't they make a pill that does the same thing to Carbs instead of fat? The American diet has tons of bad carbs rather then bad fats.

I believe they have so called "carb blockers" .

Very good and informative article Leigh. In a few years when I see the attorney commercials, I will think of you.

My other post was mainly exploring the theory of the aversion aspect that Alli could have. However, that most certainly did not account for the risk of cancer etc that you have pointed out here - good find.

Actually we have a lot of bad fats. Think fast food and the amount of fat in the fries or burgers. Thing is, it is not the good fats, but a hefty over serving of saturated fats. With 66% of the American population overweight, I look at in terms of calories, not the bodies response to a single nutrient. Fat does have 9 calories per gram as you know. Remember also, before the low carb craze, there was the low fat epidemic.

Great article Leigh.

Why can't people just show some willpower and stop eating rubbish food?

Good article, people taking pills to cover their dietary weaknesses are going to loose one way or another that is all there is too it.