Sunday, July 13, 2014

The FDA Calls One of the Body’s Basic Healing Functions a “Disease”

© ANH

Why? To make sure Big Pharma gets a monopoly on new drugs connected to it!

Inflammation is the body’s complex biological response to harmful stimuli such as pathogens, irritants, or injuries. It’s a natural, protective attempt by the body to remove the stimuli and start the healing process. When this inflammation becomes too intense or chronic, the inflammatory response itself can damage tissues. Atherosclerosis, asthma, allergies, autoimmune disorders, celiac disease, rheumatoid arthritis, sarcoidosis, and even cancer are all triggered or caused by or involve inflammation.

Although it is a natural protective response of the human body, the FDA has decided that inflammation is, in and of itself, a disease, and that statements about the ability of a supplements to treat inflammation are “implied disease claims.” FDA issued at least ten warning letters in 2013 to companies for making alleged disease claims correlating dietary supplements to inflammation. Moreover, more than 150 companies—many in the practitioner channel—also received warnings from FDA in the early months of 2013 demanding that the companies discontinue all product claims related to inflammation. Based on these actions, the agency may consider any mention of “inflammation” to be a disease claim.

A source told ANH-USA that the FDA rejected a supplement company’s pre-marketing application which said that the product “supports healthy inflammatory response.” Under the landmark Dietary Supplement Health and Education Act of 1994, supplements are allowed to make claims about how a supplement may affect the structure and function of the body (“structure/function” claims), and this statement would seem to fall squarely in the structure/function category—but that’s not how the FDA is treating it.

Why is the FDA doing this? Because Big Pharma has some anti-inflammatory drugs in the pipeline, and they want a monopoly on its treatment. So they pressure the FDA, which receives an inordinate percentage of its operating budget from the pharmaceutical industry, and the FDA issues its warning letters. Here are just a few of the products being developed:
  • Five new drugs for inflammatory bowel disease, together with four new applications for existing drugs, are currently under investigation.
  • The FDA just approved Entyvio, which treats inflammation connected to Crohn’s disease.
  • Pharmaceutical company Gilead has nine drugs in various stages of clinical trials for inflammation in relation to cancer. Two of them have already been submitted to US and EU regulatory agencies for approval.
  • Evidence from clinical trials suggests that statin drugs, which claim to treat high cholesterol, are also anti-inflammatory. If statins gain new traction as anti-inflammatory drugs, drug companies may have found an additional way to further reduce competition from supplements. Of course, as our readers know, statins come with serious side effects, such as muscle pain and depletion of the vital heart nutrient CoQ10. Since the heart is a muscle and depends on CoQ10, the current rise in heart failure could well be linked to statin use.
Whatever the prospective merits or demerits of these drugs, inflammation is not an abnormal “disease” state of the body. It’s part of the body’s underlying maintenance system, and can be triggered by something as simple as stubbing your toe. By the FDA’s ludicrous definition, we wonder if the inflammation that results from stubbing your toe would be considered a disease too!

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