The Myth of FDA Approval

There is something of a battle raging over whether or not you should continue to enjoy free access to nutritional supplements.  Though never directly mentioned in the mainstream media, there is much going on behind the scenes — both at the Food and Drug Administration and with Codex.

We see some indication of this with the occasional report in the news about ephedra or studies on the safety of vitamin E.  These reports are neither good journalism nor good science.

And that's the point.

Just as they have done since the rise of the dietary supplement industry in the 1960s, the FDA has been engaging in a campaign of misinformation designed to scare the public away from these "untested" — and therefore potentially dangerous — substances.  (See the Well TV website for the truly excellent DVD by film-maker Kevin Miller, narrated by Dame Judi Dench, on how, under the current healthcare system and its threats to our health freedom, We Become Silent.)

Are nutritional supplements safe?

Despite a long history of safe and effective use, the FDA would have us believe that nutritional supplements are inherently dangerous because they have not been evaluated and approved by the FDA.

One of the supposed dangers of these supplements is the issue of their "purity" — which, in medical jargon, means: reduced down to their "active ingredient".  I used to go around and around with my medical doctor on this point.  He would tell me not to take herbs because of their lack of purity.  Pharmaceuticals are so much safer, he said, because with them, the active ingredient of the original plant is extracted in a pure form, so you have an essentially herbal substance — in a precise dosage — without the other factors in the herb that are unstudied.

But there are problems with this theory.  They include:

• Pharmaceutical companies are taking substances that have used safely and effectively, in some instances, for thousands of years and turn them into something that causes significant side-effects and, in too many instances, death.
• One of the things that makes herbs and other quality nutritional supplements safe and effective is their lack of "purity".  In their natural state, the so-called "active ingredient" in an herb is balanced and mollified by other naturally-occurring substances, often with a synergistic effect that makes them far more effective than their pharmaceutical "copy".

There is a basic flaw in the thinking of the medical community.  That flaw is codified in Germany and much of the EU, but it's pervasive in the thinking of doctors in America.  The thought is this: If something has any therapeutic value — if it has any effect upon body systems that promotes health — it is, by definition, a drug.  In this line, if you eat an orange because you have a cold, and if that orange has any effect to relieving that cold, it is a drug.

Now, the FDA and the AMA don't take things that far in terms of fruit, but that is the thinking behind their concern over herbs and other nutritional supplements.

It really comes down to who will have control over your health: you or the medical/pharmaceutical establishment.

Does FDA approval equal safety?

But, do you really want to surrender your health freedom to the FDA or the AMA?  Let's think about this.

• After much testing, the FDA approves HRT, with the resulting death of how many?
• After much testing, the FDA approves Vioxx and other Cox2 inhibitors, resulting in how many deaths?
• In America today, the leading cause of death is the medical/pharmaceutical establishment.

The number of iatrogenic (i.e.: induced by doctors) deaths is 783,936 each year.  That's like a jumbo jet crash every day of the year.  And the sadder truth about this ghastly figure is that it's a conservative number.  Some experts estimate that it could actually be five-to-twenty times higher.  Compare that to an annual death rate of 699,697 for heart disease or 553,251 for cancer, and you can see how big a problem our medical community poses for us.

One of the contributing factors to this horror is that doctors buy in to the idea that, if the FDA approves a drug, it must be safe.  When they read the warnings on the drug literature, they minimize its significance, instead of taking it seriously.  One doctor told me that, if you read the warnings on a drug before taking it, you'd never, ever take it — it's better to just ignore the possible dangers and hope for the best.  Another doctor told me that the literature can't be taken all that seriously because regulation require that every adverse event be recorded in the literature.  It doesn't matter that, during testing, a particular drug caused serious injury or death to some people; the FDA finally approved it, so it must not be dangerous.  (Of course, we know now how often these adverse effects are hidden during the approval process.)

And these are the guys the FDA relies on — in its twisted thinking — to keep the public safe.

The fact is, doctors tend to base their prescribing decisions far more on the pharmaceutical salesman and the fact that something is FDA-approved than they do on the literature attached to the drug itself.  But let's look at some details here:

• According to JAMA (May 2002): 20% of recently-approved prescription drugs have serious, life-threatening side effects.
• According to JAMA (February 2002): 90% of authors of clinical practice guidelines received research funding from, or acted as consultants to, a drug company.
• According to the Wall Street Journal (March 2002): US direct-to-consumer drug ad spending soared to $2.49 billion in 2001, up from $859 million in 19997.
• According to the Los Angeles Times (December 2000): Seven drugs [recalled by the FDA between 1993 and 2000 after reports of death or serious side-effects] exceeded $5 billion in sales before being withdrawn [from the market].

What does this tell you about the value of FDA-approval?

Safety and FDA-approved pharmaceuticals

In watching Kevin Miller's film, We Become Silent, I was struck by something significant: Back in the early 1960s, the FDA saw its responsibility as guaranteeing that the pharmaceuticals that made it to the market were both safe and effective.  It operated as an independent governmental agency and required stringent testing of any pharmaceutical before it could be approved for use.

But things have changes considerably since then.

Today, while still partially funded as a government agency, the FDA receives about half of its funding from pharmaceutical companies.  Furthermore, up to 80% of those on the advisory panels — the guys who decide whether to approve a new drug or, as in the case of Vioxx, whether to remove it from the market — are employed by pharmaceutical companies.

The FDA is no longer a neutral, independent body of regulators.  Their interests are not primarily the public health.  They're supporting and advancing the interests of multi-billion dollar pharmaceutical companies.

And instead of the standard of safety, the new FDA has substituted the idea of managed risk and coupled that with risk-benefit analysis.  "Yes, this drug is dangerous — all drugs are dangerous.  But that's what doctors are for: to manage the use of this drug so that the harm it does is balanced by the benefits it gives."

These are the guys who want to save us from vitamin E.