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Dr. Mercola
July 09 2007
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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Public Citizen cited unpublished studies on Orlistat, showing: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 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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Community Comments ( 30 )
 		Comment on this Article
  
  
annapavlova42
 [ Joined on 02/07 ] [ Posted on July 6, 2007 ]
14 Points        
   
 
Savvy User
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.

 [ Reply ]
Mercola
  
Matt79
 [ Joined on 08/06 ]  [ Posted on July 6, 2007]
7 Points        
   
Savvy User
  Mercola
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
  
  
Katy B
 [ Joined on 03/07 ] [ Posted on July 6, 2007 ]
13 Points        
   
 
Savvy User
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.
 [ Reply ]
Mercola
  
minnie-me
 [ Joined on 02/07 ]  [ Posted on July 7, 2007]
5 Points        
   
Savvy User
  Mercola
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!
  
  
mmc88121
 [ Joined on 11/06 ] [ Posted on July 6, 2007 ]
12 Points        
   
 
Moderator User
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
 [ Reply ]
  
  
naynay
 [ Joined on 06/06 ] [ Posted on July 10, 2007 ]
9 Points        
   
 
Novice User
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.
 [ Reply ]
Mercola
  
minnie-me
 [ Joined on 02/07 ]  [ Posted on July 13, 2007]
4 Points        
   
Savvy User
  Mercola
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!!!! 
  
  
Russ Bianchi
 [ Joined on 09/06 ] [ Posted on July 6, 2007 ]
9 Points        
   
 
Savvy User
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.
 [ Reply ]
  
  
Reesacat
 [ Joined on 01/07 ] [ Posted on July 6, 2007 ]
8 Points        
   
 
Savvy User
The reason this stuff gets passed through is there is a demand by the public for diet pills no matter what the cost to their health.  The drug companies are bottom-line in it for the money, and would not risk lawsuits unless they could get a big profit.

I am not suprised, like PepperR23 said-you mess with your digestion, bad things happen.
 [ Reply ]
  
  
PepperR23
 [ Joined on 06/06 ] [ Posted on July 6, 2007 ]
8 Points        
   
 
Savvy User
This is shocking that a weight-loss drug like "Alli" has been approved for over- the- counter use.  I am not suprised that a number of people developed gall stones as a result of taking it.  Any time we mess with fat digestion, we are in for trouble.  This article is a "must read" for all who know people that are trying to lose weight and might fall for the marketing tactics of this drug.
 [ Reply ]
  
  
goldeneagle
 [ Joined on 04/07 ] [ Posted on July 7, 2007 ]
7 Points        
   
 
Savvy User
Well, then all the outraged doctors need to make sure that their patients do not take it.  Better yet.  All the outraged doctors pool enough money to take out a television ad that tells the truth about this poison and they can all rest better at night knowing, they contributed to the welfare of the populations, and sacrificed some $$$ to do it.

If people see that doctors do not like this stuff, the population will follow sound advise.
 [ Reply ]
  
  
Magnolia
 [ Joined on 06/06 ] [ Posted on July 6, 2007 ]
7 Points        
   
 
Savvy User
All of us who have friends who diet to lose weight, need to forward this article to them. Now, that doesn't mean all of them will read it, but if it saves just one person from making a dangerous mistake, its worth it. Those who choose to ignore the truth will undoubtedly suffer. We can't get too upset about them if we offer accurate data and they still insist on doing the wrong thing. Just send the article and let the ball be in their court.
 [ Reply ]
Mercola
  
minnie-me
 [ Joined on 02/07 ]  [ Posted on July 7, 2007]
7 Points        
   
Savvy User
  Mercola
I already have. A friend who is maybe 10 lbs overweight, was waiting for the day Alli reached the shelves of CVS. I read an article earlier on mercola.com...the one that originally talked about the yucky "end results" of Alli, and sent it to her. She was so grossed out! Disappointed... but disgusted enough to change her mind about buying it!  When she called me, I was quick to remind her that continuing to exercise, cutting out soda and reading labels to eliminate processed foods would probably be enough to loose that 10!
Mercola
  
rrochon
 [ Joined on 07/07 ]  [ Posted on July 26, 2007]
2 Points        
   
Novice User
  Mercola

I recently purchased Dr. Al Sears book, "PACE", and have lost about 4 pounds exercizing only 12 minutes three times a week, but the main benefit is that my blood pressure has dropped quickly from in the 150's/80's to 130's/60's. I have not changed the way I eat, which has been to watch the carbs I eat. Not too much starch or sugar.
  
  
phooey
 [ Joined on 02/07 ] [ Posted on July 9, 2007 ]
5 Points        
   
 
Savvy User
Doctor's outraged? Well, welcome to our world. How nice of you to wake up and smell something other than the perfume of the half naked big pharma reps and free samples.. Better late than never?
 [ Reply ]
  
  
Suzanne_203
 [ Joined on 08/06 ] [ Posted on July 8, 2007 ]
5 Points        
   
 
Apprentice User
Soon we'll be able to tell who's taking Alli by looking at their pants.  If you start to see people running for cover while covering their butts, look out.
Sorry I couln't resist.
 [ Reply ]
  
  
Katy B
 [ Joined on 03/07 ] [ Posted on July 7, 2007 ]
5 Points        
   
 
Savvy User
article: These dangers become even more worrisome because the drug’s efficacy is minimal at best.

Hahahah the joke is on the consumer, AGAIN!  How many doctors were outraged?  The ones who didn't get pre-paid for prescribing these poisons?

Oops, sorry, I know there are good doctors, I know because people tell me there are, I've only met one~this was long before they all became drug pushers.  Then of course Dr. Mercola, but I'm talking about personal knowledge.

How long will it actually take these poor dupes to lose weight with their new alli?  How long will it be for the to lose their health?

Katy B.

 [ Reply ]
  
  
craynewhope
 [ Joined on 03/07 ] [ Posted on July 26, 2007 ]
1 Points        
   
 
Apprentice User

When and how can we get a grass roots move against FDA, to get the old one removed, and get a for the people department started?

 [ Reply ]
  
  
akstutz
 [ Joined on 03/07 ] [ Posted on July 27, 2007 ]
       
   
 
Novice User

Well, I STUPIDLY ignored all warnings about this drug that I found on the internet.  Of which, I did not find cancer nor gallstones in the list of potential side effects.  I read the drug info and followed the plan closely.  I did the low fat diet for 1 week before starting the pill use.  I lost 5 pounds.  I then began taking the pills for 8 days, a total of 21 pills were taken-I took a multi-vitamin and Juice-Plus and drank at least 64 ounces of water during each of these days.  I lost about 7 more pounds.  On the eighth day, I had a stomach ache.  I told my husband I would stay up for a while until it went away.  I took a couple of tums and dozed in the easy chair for about 10 minutes.  I was then awoken with severe abdominal pain.  I could barely walk to the bedroom to wake my husband.  I was cold, sweating, vomitting, and in extreme pain.  My husband called the hospital's "ask-a-nurse" help line.  They suggested I come to the ER.  I didn't wait to call my doctor for a second opinion--It was midnight.  Luckily, the ER was not busy when I got there.  The ER staff got my pain under control in about 15 minutes with some pain medication and probiotics.  Over the course of the next couple of hours, it was determined that I had severe pancreatitis; most likely caused by a gall stone.  My Lipase level was 20,000 (it is usually around 40) and my amylase was around 7500.  I was admitted to the hospital and spent the next 64 hours on an IV with no water or food so that my pancreas could rest.  The errant gall stone left my system as quickly as it had blocked up the common bile duct.  I am scheduled to have my gall bladder removed on August 28th as the ultrasound showed that it is full of gall stones.  I currenly have no symptoms; but I never want to experience the pain again. I am obese, age 36, non-drinker.  I've never had abdominal trouble.  I had a C-section in 2005 because my little guy had decided he didn't want to come out :) .  Warn everyone....STAY AWAY FROM ALLI !

 [ Reply ]
Mercola