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.