Cho 32 – FDA 300,000 a year

Action memo: You have one week left to block the FDA killing machine, or millions may die.

The Federal Death Authority is on the attack again.

Not content to dominate the drug trade and send your prescription drugs into the $tratosphere, the Food & Drug Administration is now trying (yet again) to take over the entire health food and nutritional supplement industry so they can shut it down forever, leaving expensive FDA-approved drugs – with their myriad side effects – as your only option for treating anything from Alzheimer's to zits.

I've been active in the alternative health field since the '60s – as a writer, a manufacturer, a salesman and a grateful patient. I've known and written for some of the greatest names in the alternative field, and I once even had to hire an FDA veteran to help me navigate their bureaucratic maze in Washington. So I know the turf somewhat, and I know the mindset of the main players, the biggest being that 800-pound FDA gorilla with its SWAT-team enforcement division that loves to raid doctors' offices and shut down health food stores.

If your eyebrows jumped a bit at the idea of armed FDA agents behaving in Gestapo fashion, here's a typical site, with 15 brief examples. Click on the second bullet. (Warning: If your blood pressure is over 160/100, pass on it – or check out a less inflammatory site.)

But I digress. We have a major problem. The FDA is proposing new "guidelines" (Document 2006D-0480) that will eventually give the agency total control over the health food and supplement industry, which they despise and want to destroy. You have only until April 30, 2007, to make your feelings known about this deadly power grab. So speak up. Or, if you're a fan of legalese, you can read the whole document.

The FDA has been on this kick forever. I was born in the year the FDA was put into its present form, 1938, and ever since I can remember, they've been on a power trip surpassed only by Genghis Khan. I still have dim memories of a long-ago FDA retirement banquet for their point man in charge of shutting down the health food industry. Fortunately, I've forgotten his name and Google refuses to cough it up, but I do recall that during his speech he was chortling about what fun it had been to be their designated bastard for so many years. (I think the actual term he used was a bit more unprintable, but that's close enough.)

The FDA hacks are pooh-poohing the significance of the new guidelines as toothless suggestions that merely "clarify" and "change nothing." Yeah, right. In truth, they're following the classic procedure for passing outrageous laws that wouldn't have a chance without an incremental, camel-nose-under-the-tent approach.

In reality, 2006D-0480 would eventually change everything, including your life expectancy. The FDA realizes that alternative medicine has far, far more solutions to chronic diseases than mainline medicine does ... and that panics them because they know Americans now visit complementary and alternative medicine practitioners more often than "ortho-docs." They know that the once-obscure supplements of 1990 are now in every Safeway, Walgreen's and Wal-Mart. They know that alternative doctors are now curing advanced cancer, heart disease, arthritis, etc., every day of the week. In contrast, a physician friend and top authority tells me that the mainline medical establishment actually cures only 4 percent of cancers in the U.S. today.

In short, they know they're starting to lose the battle, and their only chance is an under-the-radar power grab like 2006D-0480. What it does is this: Whenever you make a claim that some substance may help to clear up somebody's health problem (like chicken soup for a friend's cold), whammo! You are henceforth claiming it's a medicine and a drug! It decrees that no food, vitamin, mineral, enzyme, etc., will henceforth be allowed to heal anything. If it does, it instantly becomes medicine and will be subject to all their rules on billion-dollar drugs.

How on earth can they do that?

Easy. They have already decreed, in their boundless whizdom, that a medicine is anything you make a medicinal claim for! Abracadabra shazam! You speak the word, and it's done. If you and some friends start saying that Big Macs cure dandruff, voil?! – the FDA is technically authorized to confiscate every Big Mac in the U.S. (Whoa! Just think of the health benefits.)

Don't laugh. In 1990, something rather like that was done. One batch of l-tryptophan from one company in Japan was contaminated. Now, tryptophan is just one of the essential amino acids, but people call it a sleep and calming aid, so on March 22, 1990, FDA bureauquacks seized upon that one bad batch as an excuse to confiscate every bottle of tryptophan in the country ... and keep tryptophan off the market until February 2001 – by whim and decree! (And guess what: Only four days after the seizure, March 26, 1990, Prozac was introduced publicly – in Newsweek – and sales took off like a rocket. But in the interest of staying out of jail, I'll refrain from comments on that amazing coincidence.)

Here's the crux of the problem with the "new guidelines": Once the FDA has declared a vitamin, mineral or health food to be a medicine, the manufacturer will have to prove its efficacy just like any big pharma drug. So how do you do that?

Let's suppose you come down with Lou Gehrig's disease. You quickly discover that government-approved medicine has no cure, and you're a dead man walking.

But then you remember that your old Uncle Phineas said eucalyptus liniment would cure anything. So you mix up a batch and rub it in daily, and whaddya know, the ALS goes away. (Hey, did you ever see a koala bear with ALS?) You excitedly mix up more batches and sell it to other sufferers, and they, too, get well. Whee.

Will the world beat a happy path to your door and laud you with eternal gratitude? No, I guarantee what will come up your path is a squad of FDA gentlemen with handcuffs ... unless you do the proper testing to meet the new FDA guidelines.

And how much will that cost you? Oh, about $800 million, typically. And just how are you supposed to pay for that? Gosh, that's your problem. Do you know a really good banker? Maybe they'll let you pay the loan back out of your profits after you patent your liniment and start manufacturing in your garage.

Woops, my bad. You can't get a patent on eucalyptus sap.

It's a lockout system. We have millions of potential inventors, but only a few big pharmas that can create life-saving cures. Weep for America.

A special word to Andrew C. von Eschenbach, M.D.

As the new commissioner of the FDA (since December), you have inherited a sizeable pile of manure from your predecessors. We'll make allowance for that. We'll also make allowance for your status as a former cancer patient, which we sympathize with. And we'll also accept the general consensus that you're a nice guy.

But there are limits to our forbearance, sir, and you have allowed this horrendous plan to move ahead on your watch.

Admittedly, your agency does save lives in various ways. Its saving grace is that when some crook puts one set of ingredients in a bottle or can and a different set on the label, your agents get absolutely livid. That's cool. But overall, Dr. von Eschenbach, you are in charge of a death machine.

It's impossible to pinpoint the yearly toll because your agency's shadow falls on so many paths. But …

One noted doctor claims that 106,000 die annually from "good," FDA-approved drugs even though they were prescribed and administered quite properly.
Personally, I feel that another 150,000 deaths (at least) can be attributed to the suppression of reasonable and promising alternative modalities that your super-tight regs don't allow.
And there must be at least another 50,000 a year who fall victim to treatments in the "Vioxx7 and chemotherapy class" – approved drugs that kill more people than they save.

All told, in my opinion, 300,000 FDA deaths a year is a lowball figure. That means, for example, that in the three hours it took one slimebag at Virginia Tech to kill 32 people, your machine quietly squeezed the life out of a hundred or so.

As layman citizens who are more knowledgeable about nutritional therapies than the average doctor of 30 years ago, we strongly urge you to use your influence to block the adoption of 2006D-0480 and save perhaps millions of lives in the decades ahead. The dark era of elitist, power-based medicine is fading, sir. Please take your place in history as the man who dragged the U.S. government into the light. Your children and grandchildren will bless you for it.

(Declare your thoughts to Dr. von Eschenbach.)

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