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Doctors Outraged--FDA Ignored Cancer Risk When Approving Alli

In February 2007, the FDA approved Alli--an over-the-counter version of the diet drug Orlistat (Xenical).

The Public Citizen‘s Health Research Group has voiced concerns about Orlistat’s safety and efficacy for the past 10 years, as it‘s been shown to cause pre-cancerous lesions of the colon.

In April of 2006, a group of doctors with Public Citizen petitioned the FDA to ban Orlistat and deny OTC status to the lower dosage version Alli, offering testimony that Orlistat raises the risk of both colon cancer and gallstones.

Public Citizen cited unpublished studies on Orlistat, showing:

  • Orlistat increases the precursor markers to colon cancer by 60 percent in rats.
  • When eating a high fat diet and taking Orlistat, the cancer risk increased 2.4 fold.
  • Fat soluble vitamin E depletion, due to Orlistat‘s fat blocking action, raises the risk of colon cancer even further.
  • Recorded adverse reactions to Orlistat include: 39 cases of increased abnormal blood thinning; several cases of bleeding episodes; 10 hospitalizations, four with life threatening reactions, and one death.
  • Dangerous thinning of the blood can occur in people taking drugs like Warfarin (an anti-coagulant), or who suffer from vitamin K deficiency.

In addition, the FDA itself found 37 cases of gallstones in patients of all ages, between 1999 and 2006, prior to releasing Alli for over-the-counter sale.

The safety analysis from the Public Citizen‘s Health Research Group is that Alli "has marginal weight loss benefits, common and bothersome G-I tract reactions, significant decrease in absorption of fat soluble vitamins, and problematic use in the millions of people using Warfarin or Cyclosporine."

The FDA denied Public Citizen‘s petition on the same day they approved Alli as an OTC.

Public Citizen‘s Health Research Group

Statement to the FDA of Dr. Wolfe February 2007

Petition to the FDA to Remove Orlistat April 2006

Testimony Before the FDA Advisory Committee January 2006

Alli and Gallstones June 2007



Dr. Mercola''s Comments Dr. Mercola's Comments:

The sad truth is, although obesity is rampant, OTC diet pills are often purchased by women who are not obese at all. One of Public Citizen's main concerns over the approval of Alli for over-the-counter sale, is that countless numbers of people will expose themselves to radical and unnecessary health risks, for no reason whatsoever. I agree with their sentiment.

I doubt if you will ever see any "drug" that will prove successful for weight loss. I thought that would also be true for any "pill' but earlier this year I became aware of a brown seaweed product that actually helps increase metabolism naturally. Of course it needs to be used in conjunction with a comprehensive lifestyle program, but it really does seem to work.

Alli is marketed as a "plan," which includes a low fat diet and exercise. But honestly, you'd get superior results from the last two alone, without the embarrassing side-effects and the potential onset of lethal diseases.

But people are always looking for a quick, easy fix, and the drug companies are ever so happy to accommodate them. There is no miracle, one-shot cure, and adding a pill to your weight-loss plan will only make it worse, not better.

In fact, dieting is actually a consistent predictor of future weight GAIN; those who participate in formal weight-loss programs usually gain significantly more weight over a two-year period than those who have never participated in such a program.

But this is because most diets are based on myths and half truths. The good news is that there are very effective tools you can use to lose weight successfully:

  • Eliminate grains and sugars from your diet
  • Add cardiovascular exercise for one hour a day seven days a week at an intensity that is challenging enough to make it difficult for you to talk to someone next to you
  • Address the underlying emotional challenges that are keeping you from changing your habits


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Comment on This Article Community Comments (30)
 
 
Posted On Jul 06, 2007
Around and around we go, where we stop, no-body knows.

After reading this article I could not help chuckling a little.  Why you ask?  Not because this is funny, but because I am so angry, I need to laugh to maintain a normal blood pressure.

I feel so speech-less, I am nearly in tears.

We can only hope that Ron Paul will get in office.  I firmly believe that he, among others, will save us from total destruction.

This is a very dangerous game of life THEY are playing, and the out-come will test the waters of all man-kind.


 
annapavlova42
Savvy User Savvy User, Joined On 2/2007
annapavlova42  
Replied

Matt79
Savvy User Savvy User Joined On 8/2006
Matt79  
 
Posted On Jul 06, 2007
I too am unable to react normally when I hear this stuff.  I am too young (28) to be so pessimistic about our government and life in general but the more I discover and learn the greater my pessimism gets.
So I sometimes laugh or get upset or just stop caring.  Its a sad state the we allow ourselves to get forced into

 
 
 
Posted On Jul 06, 2007
They learned nothing with Phen-fen, and this will be another huge lawsuit, the thing is the drug manufactirers make so much $$ on a bad drug that even paying out lawsuits doesn't cut into their profits. 
The only way to lose weight is to reverse the process that put it on in the first place, lessen the amount of intake and get that body moving, instead of eating too much and couch potatoing.

Katy B.

 
Katy B
Savvy User Savvy User, Joined On 3/2007
Katy B  
Replied

minnie-me
Savvy User Savvy User Joined On 2/2007
minnie-me  
 
Posted On Jul 07, 2007
Nope! As a society, we've learned to depend on the quick fix.  Excess weight is hard to take off  because of addicting food additives. Once introduced into the body, human metabolism has been altered. Children are fed msg in hidden forms as soon as they can eat solids. Aspartame gives us the false sense of security that we are not getting added sugar, therefore zero calories!
It stands to reason that young girls who are overweight at 15, want to wear the tiny tine trendy clothes that are being worn by their "fit" friends. So they are led to believe that a miracle pill will make them skinny without the discipline of eating right and exercising!
Then, when they abuse their bodies and get cancer, the law suits come flying.  Obviously, we are not just talking about teenaged girls....
People need to be aware...read...research...and DON'T support these drug companies by falling for their dangerous lies!

 
 
 
Posted On Jul 06, 2007
Their are two main problems with this drug.  One is that people want a quick fix and two is that many people think the FDA is there to protect them.  Neither one is correct.

Mary

 
mmc88121
Moderator User Moderator User, Joined On 11/2006
mmc88121  
 
 
 
Posted On Jul 06, 2007
For all their posturing, the so-called regulators at Fraud Deceit Always, are protecting no one be their own backsides and those on K Street who own them.

 
Russ Bianchi
Savvy User Savvy User, Joined On 9/2006
Russ Bianchi  
 
 
 
Posted On Jul 10, 2007
This drug is completely ridiculous.  My son has Cystic Fibrosis.  He can't absorb fat without taking enzymes every time he eats, and what happens if he eats too much fat with too few enzymes?  He has grease bowel movements.  He has bloating, gas, and abdominal pain.  These are not good symptoms and mean that he got basically no nutritional value from what he ate whatsoever and we have to constantly monitor his fat soluble vitamin levels because if you don't absorb the fat you don't absorb the vitamins.  Before we found enzymes that actually worked well for him he had around 10 extremely foul smelling bowel movements a day along with quite a bit of discomfort.  He would give just about anything to not have to take his enzymes and be like everyone else.  I can't believe that people would actually pay money to have some of the symptoms of this devastating disease.

 
naynay
Novice User Novice User, Joined On 6/2006
naynay  
Replied

minnie-me
Savvy User Savvy User Joined On 2/2007
minnie-me  
 
Posted On Jul 13, 2007
I agree with you, naynay...and I'm glad that you found the right enzymes for your son. It has to be very difficult and frustrating to not be able to absorb the nutrients that he eats. 
 He should be the spokesperson against these stupid drugs!  
I wish him the best!!!! 

 
 
 
 
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