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Doctors Outraged--FDA Ignored Cancer Risk When Approving Alli

July 09, 2007 | 41,714 views
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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Public Citizen cited unpublished studies on Orlistat, showing: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

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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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