FDA - Money, Politics, Power-Brokering and YOU!

Anyone who's ever seen or read an ad for a nutritional supplement is familiar with the legal disclaimer stated above. Personally, I've always found it a bit of a joke, as if Roger Federer told you something about his tennis racket and then had to say "these statements have not been evaluated by my golf pro".

Though I have no doubt that there are honest and serious and good people working at the FDA, the whole idea that the FDA can seriously evaluate vitamin research and should be the final word on what consumers should take has always struck me as kind of ridiculous.

A recent disclosure in the New York Times illustrates how much deeply both "scientific" research and FDA approval can be influenced by money, politics, power brokers and economics.

Here's what happened: a knee-repair device called Menaflex which is supposed to cushion stress in the joint and encourage regeneration of tissue was tested in a clinical trial in the 1990's where it was found to be no better than standard surgery; not only that, there were some concerns about safety.

So the company- ReGen Biologics of Hackensack NJ-applied for "fast-track" FDA approval which bypasses the need for proof of safety or efficacy. All that's required for approval is a finding that the device is "substantially equal" (no worse than) others on the market.

Problem is, the FDA scientific reviewers found no such thing.

But that didn't stop the company. They complained of unfairness and applied pressure to New Jersey lawmakers to "lean" on the FDA.

Which the lawmakers did. And before long, the FDA ruled that the device was indeed "substantially equivalent" to others on the market. This decision was made by a panel of outside experts, but ReGen was able to prevent those experts from hearing direct testimony from the scientific reviewers.

Nice work if you can get it.

The FDA now acknowledges that it received "extreme" pressure from four members of the New Jersey Congressional delegation who clearly influenced a decision that was supposed to be made on scientific grounds. (The FDA is now reviewing its decision to approve Menaflex.)

I can't prove it but I think this stuff goes on all the time.

There are deep biases in much of the "research" conducted on vitamins, and profound economic reasons why drug companies do not want the public to hear positive reports about "natural", non-patentable alternatives to pharmaceuticals. And these folks have connections and deep pockets.

"What the research shows" can be so easily influenced by what research you choose to present, who winds up hearing (and evaluating it), who did the research in the first place, and what they stand to gain by it.

Please try to remember that the next time you read (or hear) an alarmist headline like "multivitamins kill" or "vitamin E shortens lives".

It's time we look a little more closely- and listen a little more critically- to what we hear about vitamins and supplements (and yes, drugs!) from the media.

Oh by the way- these statements have not been evaluated by the FDA.

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25 Year Heart Surgeon Reveals The Statin Scam

Guest article by Dr. Dwight Lundell:

Television ads featuring artificial heart inventor Dr. Robert Jarvik (who never practiced medicine) claims that Lipitor will lower heart attack risk by 36%.

Now, who wouldn't want that? Let's look at the fine print...

"in a large clinical study 3% of people taking a placebo had a heart attack and 2% of those taking Lipitor had a heart attack."

Let's do the math...

• For every 100 people in the trial that lasted 3 l/2 years, 3 people on the placebo and 2 people on Lipitor had heart attacks. That is one less heart attack for every 100 people.
• In other words, 100 people had to take Lipitor for 3 l/2 years
• to prevent one heart attack.
• What this really means is, 99 out of 100 people taking Lipitor received no benefit.

There is a little known statistic, "Number Needed To Treat," (NNT) defined as the number of patients who need to be treated in order to prevent one bad outcome. In the case of Lipitor, 100 patients needed to be treated for 3 l/2 years to possibly eliminate one heart attack.

Let's compare that number to today's antibiotic treatment to eradicate ulcer causing H. pylori stomach bacteria. The Number Needed To Treat H. pylori is 1:1. That means if you give the antibiotic to 11 people, 10 will be cured.

Several recent scientific papers peg the NNT for statin medications at 250. That means 249 of 250 would receive no benefit.

Dr. Jerome R. Hoffman, Professor of Clinical Medicine at UCLA asks:

"What if you put 250 people in a room and told them they would have to pay over $1,000 per year for a medicine they must take every day that might give them diarrhea and muscle pain and that 249 of those people would get no benefit, how many would take that?"

Very, very few.

Drug companies have a responsibility to their shareholders to make a profit. We need drug companies to develop new medicines; however, when they grossly overstate benefits and spend enormous dollars influencing physicians, it leads to potential corruption.

The National Cholesterol Education Program (NCEP) 2004 guidelines lowered the targets for cholesterol treatment and recommended more Americans take statins. The panel that issued the guidelines was comprised of 9 experts, 8 of which had ties to the drug industry.

Physicians who speak out take great risks as medicine and government agencies do not like criticism. For example, Dr. Henry C. Barry of the Michigan State University College of Medicine recently stated, "The NCEP guideline and process went awry."

Dr. Barry and 34 other experts sent a petition of protest to the National Institutes of Health saying the evidence was weak and the panel biased because of its ties to the drug industry. Dr. Rodney A. Hayward, Professor of Internal Medicine at the University of Michigan Medical school said, "current evidence supports ignoring LDL cholesterol altogether."

In response to these statements The National Cholesterol Education Program stated strongly, "Dr. Hayward should be held accountable in a court of law for doing things to kill people."

We might expect this kind of harsh response from zealots and extremists but not from government agencies or scientists. If we spent just a fraction of the money we now do on cholesterol testing, cholesterol lowering drugs and doctors visits, on educating people about proper diet, exercise and weight loss, we'd be far healthier.

Dr. Lundell's New Book Backs What I've Been Saying About Cholesterol for Years!

The Great Cholesterol Lie Why Everything You Learned About Cholesterol Is A Lie, How It Began in 1948 And Why It Continues. Why Statin Medications Will Not Reduce Your Risk Of Heart Disease, And What Will. Extraordinary Simple Steps That Prevent And Reverse Heart Disease Without Medication. Learn More

Treating Cravings and Addictions with Food and Supplements

You may never have been addicted to drugs, but you might know something about the addiction to food. Or sugar. Or alcohol. Or gambling. Turns out that all these addictions- and the associated cravings- have more in common with one another than you might think. And interestingly enough, the key to managing them might be in your diet.

This week's issue of The Economist, a London based newspaper, reports on interesting ongoing research using dietary approaches to addictions.

Here's how they explain the problem:

"People are programmed for addiction. Their brains are designed so that actions vital for propagating their genes- such as eating and having sex- are highly rewarding. Those reward pathways can, however be subverted by external chemicals (in other words, drugs) and by certain sorts of behavior such as gambling."

We also know from animal experiments that reward pathways in the brain can be hijacked by sugar. Rats who became addicted to sugar actually showed all the signs of cocaine withdrawal when sugar was removed from their diet.

The key to the whole thing- no big surprise- is in your brain chemistry, that complicated computer system where messages can frequently get corrupted and things can easily go astray. Addictive substances literally "hijack" the pleasure centers of the brain so that it's harder to obtain regular plain old garden-variety pleasure from regular activities. Instead, you need bigger and bigger doses of the substances or behaviors that give you the biggest jolt- sugar, cocaine, drugs, alcohol, gambling and the rest of the usual suspects.

One supplement that's getting a lot of research attention for addictions and that has remained under the radar for now is NAC- N-Acetyl-Cysteine. A study published in the American Journal of Psychiatry found that giving NAC to cocaine addicts reduced their desire to use the drug so much that the researchers recommended NAC as a potential treatment. An entirely different study found that NAC reduced the desire to gamble in 80% of gambling addicts (as compared to 28% of those given a placebo). And animal studies have shown that NAC reduces relapse with cocaine and heroin.

OK, so probably not many of you are cocaine or heroin addicts. But cravings are cravings, and if NAC works with some addictions (or cravings) it should work with others. I've recommended NAC for years as part of a liver health program since it boosts the body's level of the important antioxidant glutathione (which is not well absorbed in supplement form).

Now it looks like it may have another use!

Other nutritional factors that can support a healthy brain function are tyrosine (a precursor of the neurotransmitter dopamine), 5-HTP (a precursor of serotonin) and GABA (a relaxing neurotransmitter). My friend Dr. Daniel Amen put these together in an elegantly designed formula called NeuroLink, which also contains a nice dose of vitamin B6, needed to convert 5-HTP into the feel good neurotransmitter serotonin.