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Life Extension Magazine

Life Extension Magazine July 2009
As We See It

FDA Seeks to Ban Pyridoxamine

By William Faloon
What Makes Pyridoxamine So Special?

Scoundrels!

I yearn for the day when the public recognizes pharmaceutical companies as the morally bankrupt institutions they really are.

Perhaps the most misleading television commercial of all time was a pharmaceutical industry scientist (or actor pretending to be a scientist) claiming that drug companies sincerely care about the public’s health. While some well-meaning people work for drug companies, the actions of management reveal their only objective is to make money.

Drug company financial projections are based on aging Americans contracting lots of age-related diseases like kidney failure. Diabetes inflicts damage to tissues throughout the body by accelerating toxic glycation reactions.37,38 If too many diabetics find out about supplemental pyridoxamine, the need for prescription pyridoxamine could plummet as many incidences of diabetic-induced kidney disease could be prevented.

Drug companies have a strong economic bias for denying you access to pyridoxamine. The more glycation damage that occurs in your body, the greater your need will be for their expensive drugs.

Drug Companies Make Tons of Money Selling Supplements as Drugs

The FDA believes that allowing a drug that is being clinically tested to also be sold as a dietary supplement will prevent pharmaceutical companies from funding research. This is a false assumption.

Each year, more than $400 million of an expensive drug called Niaspan® is sold for the purpose of increasing beneficial HDL and reducing artery-clogging triglycerides (and LDL). Niaspan® is nothing more than extended-release niacin that one can purchase as a low-cost dietary supplement.39

While extended-release niacin* has long been available as a supplement, the most money is being made by pharmaceutical interests by virtue of mainstream doctors prescribing Niaspan® to their cardiac patients and Medicare/ insurance companies paying its inflated price.

Another dietary supplement that went through pharmaceutical-funded clinical trials to prove its efficacy is the prescription fish oil drug called Lovaza® (previously named Omacor®).40 Even though Lovaza® costs about seven times more than the same amount of EPA/DHA obtainable from dietary supplements, sales are exploding because many doctors are prescribing this fish oil drug to their cardiac patients. In 2007, pharmaceutical-giant GlaxoSmithKline bought the maker of Lovaza® for an astounding $1.65 billion. Glaxo paid this astronomical amount of money for the ownership of this prescription fish oil knowing full well that dietary supplement fish oil could be obtained at a fraction of the price.

FDA’s contention that pyridoxamine sales must be banned in order for clinical research to be funded is a farce designed to enrich pharmaceutical interests even more than they are now.

*Caution: Life Extension’s concern with extended-release niacin is that it can potentially cause liver damage that would not occur in response to regular niacin. The reason is that niacin interferes with healthy methylation patterns in the liver. The exposure to the liver of extended-release niacin may induce chronic methylation deficits that result in chronic liver damage.41 These methylation deficits may be prevented by taking folic acid, vitamin B12, and other methylation-enhancing nutrients.42-44

What You Can Do to Fight Back!

We know that pyridoxamine was used as a dietary supplement in the early 1990s. If we can prove that pyridoxamine was sold in the United States prior to October 1994, the FDA will not be allowed to ban it. The Dietary Supplement Health and Education Act protects supplements marketed prior to October 1994.

If you used pyridoxamine prior to October 1994, please let us know so we can add your name to an affidavit and use any evidence you have to overturn the FDA’s proposed ban on pyridoxamine.

The FDA is controlled by the Executive branch of government. Writing to members of Congress may not work since they do not directly control arbitrary FDA decisions, such as the banning of pyridoxamine at the bureaucratic level. The White House, on the other hand, can with one phone call, demand that the FDA reverse its position and allow the free sale of pyridoxamine as a dietary supplement.

We therefore urge Life Extension members to mail the form letter that appears on page 3 to the health administrative affairs officer at The White House and demand that the FDA lift its proposed ban on pyridoxamine.

Whether you suffer from diabetes or just normal aging, your proteins are undergoing glycation every second of the day. Pyridoxamine is an effective method to inhibit these lethal glycation reactions.45,46

It takes just a few minutes to mail the White House your concerns about the hideous effects that will occur if pyridoxamine is denied to Americans. The encouraging news is that initiatives are already in place to stop this kind of financial fleecing on the part of pharmaceutical companies, so The White House may be receptive to your letters.

Drug Companies Want to Also Ban Pyridoxal-5’-Phosphate

For decades, the FDA has used all kinds of pathetic excuses to try to classify dietary supplements as prescription drugs. Interestingly, conventional medicine often attacks the value of dietary supplements, while simultaneously seeking to have the FDA approve the same supplement as highly effective prescription drugs.

You have just read about the potential health benefits of pyridoxal-5’-phosphate. If a drug company has its way with the FDA, however, this form of vitamin B6 might also be banned. A drug company has recently filed a petition with the FDA to classify pyridoxal-5’-phosphate as a drug.

The basis for this petition are favorable clinical studies showing that when cardiac bypass patients are given the monohydrate form of pyridoxal-5’-phosphate prior to surgery, there is a significant reduction in postsurgical complications, including reduction in heart attack incidence.49-51 Pyridoxal-5’-phosphate monohydrate prevents cellular calcium overload in preclinical and clinical studies of cardiac ischemia-reperfusion injury.51

Once again, a dietary supplement that can benefit all aging humans (pyridoxal-5’-phosphate) may soon only be allowed in patients undergoing heart surgery—and may never get approved unless the drug company can fund more clinical studies.

The encouraging news is that there appears to be adequate documentation to prove that pyridoxal-5’-phosphate was indeed sold as a dietary supplement prior to October 15, 1994. This simple fact should preclude the FDA from banning this form of vitamin B6 that has demonstrated potent anti-glycation properties.

Engineering Around This Lethal Dilemma

The FDA’s arbitrary decision to deny Americans free access to pyridoxamine has galvanized health freedom activists throughout the United States. This may become the FDA’s “Waterloo” from the standpoint of antagonizing such a broad spectrum of the American public that the agency’s powers may be eroded through legislative action.

In the meantime, regrettably, vitamin manufacturers have been intimidated in such a way that they will no longer make supplements containing pyridoxamine. Since pyridoxamine is such a crucial anti-glycation agent, we at Life Extension have worked overtime to devise a stop-gap measure to protect our members’ vital structures from glycation-induced degradation.

The encouraging news is that there is a form of vitamin B6 that may have comparable and possibly superior benefits to pyridoxamine. When different forms of vitamin B6 (B6 “vitamers”) are ingested, the ultimate active form of B6 is pyridoxal-5’-phosphate. In laboratory studies, this form of vitamin B6 inhibits protein glycation47,48 and demonstrates more potent lipid anti-glycation3 effects compared with pyridoxamine. The chart on this page shows how much more effective pyridoxal-5’-phosphate is to any other form of B6 in inhibiting lipid glycation.

One could still argue that pyridoxamine is the preferable form. Some of the unique benefits of pyridoxamine probably derive from the pyridoxamine molecule itself. There are very few published studies that compare pyridoxamine and pyridoxal-5’-phosphate side-by-side.

For many years, it was thought that orally ingested pyridoxal-5’-phosphate is degraded in the digestive tract and does not provide systemic benefits. Published studies reveal that the pyridoxal-5’-phosphate, when swallowed, is orally bioavailable and demonstrates systemic benefits, including protecting vital kidney structures analogous to the way pyridoxamine does.11

Relying on the published scientific literature, we at Life Extension are replacing pyridoxamine in all of our products with a double-dose of pyridoxal-5’-phosphate. While the cost to us is very high, we are not about to let the FDA’s insanely prejudiced actions deprive our members of this vital vitamin B6 metabolite.

At this time, we have a limited supply of pyridoxamine-containing supplements available.

Pyridoxamine is included in Life Extension Mix, Mito-chondrial Energy Optimizer, and as a stand-alone 50 mg supplement. Once this supply is sold out, we will substitute a double-dose of pyridoxal-5’-phosphate in all these supplements, but will not increase the price.

Efficacy of Aminoguanidine and B6 Vitamers in Inhibiting Lipid Glycation3
Efficacy of Aminoguanidine and B6 Vitamers in Inhibiting Lipid Glycation3

This chart was prepared using data from the Journal of Lipid Research (Volume 47, 2006) in which differing compounds were screened for their ability to inhibit lipid glycation. As can be clearly seen, the RED bar shows far less lipid glycation in the presence of pyridoxal-5’-phosphate than any other form of vitamin B6, including pyridoxamine (black bar).

The fact that we have engineered around the FDA embargo should not diminish the urgent need to contact The White House to demand that this scientifically absurd prohibition by the FDA be reversed. While Life Extension members may obtain the same benefits from pyridoxal-5’- phosphate, most of the public will not find out about this superior form of vitamin B6, and will succumb unnecessarily to a host of age-related diseases.

In this month’s issue, we feature an in-depth article that describes the benefits of pyridoxal-5’-phosphate. I ask all members, to mail the letter on the next page to the White House to protest the inappropriate banning of pyridoxamine.

For longer life,

For Longer Life

William Faloon

Letter to the White House

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