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Is a supplement still a supplement if it prevents, treats or cures?

The dietary supplements industry has a paranoia complex, always believing somebody is out to get them. I'm here to tell you it's just not true. It's not paranoia if they really are coming to get you.

This issue came to a head at a Wednesday session at the Nutracon conference in Anaheim, Calif., where speaker Bill Sardi put forth the question, "Can a nutraceutical prevent, treat or cure a disease and still be a nutraceutical?"

On the one hand, we have evidence of vitamin C, which does indeed prevent, cure and treat the scourge disease, scurvy. Another instance is vitamin D, which prevents, cures and treats the bone disease, rickets.

So what happens when the FDA bans the use of a nutraceutical when there are no other therapeutic options available and patients could sustain permanent harm, such as vision loss or even death, without the nutraceutical?

This happened in the case of patients with wet age-related macular degeneration. The common treatment is to inject into a patient's eyeball an FDA-approved cancer drug, Avastin. This is not the approved use of Avastin, but doctors are allowed to use it off-label under the thinking that Avastin cuts off blood vessel growth. Cost: $250 per injection. Drug companies have also been able to develop an oral form of the treatment. Cost: $2,000 per treatment.

A resveratrol supplement, meanwhile, has been shown in animal studies to work on a number of levels to switch genes on and off and address underlying inflammation by suppressing expression of pro-inflammatory genes involved with vasodilation. Case studies in humans have shown resveratrol to work in as little as four days. But when the supplement was set up for a more rigorous clinical study at Duke University, the university turned to the FDA for guidelines of using the supplement in what was essentially a disease-treatment study, the FDA shut down the study before it began.

"The consequences of ignoring a nutraceutical are, in this case, there are 37,000 cases of permanent vision loss per year that could have potentially been delayed or prevented in 2008 alone," said Sardi. "You're talking compassionate use protocols—everything else failed."

Sardi noted that a number of well-known drugs came into common use without any double-blind, placebo-controlled studies, such as insulin, digitalis and penicillin.

"Today's drugs are designed to target a single gene receptor site, while polyphenols like curcumin and resveratrol hit hundreds of these sites. You can't even compare the two. But it's just that we exist in a system that won't let this information be found. It's censorship."

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