Tuesday, January 12, 2010

Who's afraid of the FDA?

I am now. I wasn’t before I read this book:

FDA: Failure, Deception, Abuse
Compiled from articles in Life Extension Magazine* and largely written by William Faloon.

Forget Salem’s Lot or A Haunting in Connecticut. This stuff is much more terrifying. The book discusses various cases in which the Food and Drug Administration is [and sometimes by its own admission] failing in its mission to protect the health and welfare of the American people.

The articles highlight instances where the FDA guidelines have allowed bad drugs to come to market despite numerous deaths, terrible side effects and poorly constructed clinical trials while oftentimes useful drugs or supplements are stonewalled or denied to needy patients.

I spend a lot of time reading the labels in the health food/vitamin aisle at the supermarket and I’ve always been concerned about those little taglines you see that say in effect: These statements have not been verified by the FDA. It’s sort of a backhanded warning for consumers. It’s not saying the bottle of supplements or the diet drink you’re thinking of buying is bad for you, it’s just saying the government agency established to safeguard your health by testing and controlling the manufacture of anything you want to put in your body hasn’t bothered to find out if this particular product does what it claims to do.

Not a glowing testimonial. Cleverly designed to make you wonder, is this stuff okay? If it’s not, why do they sell it at the supermarket? If it is, why did my doctor tell me it was all hogwash to take supplements? Am I wasting my money or endangering my health?

The book tends to lean toward the explanation that the FDA is under the control of Big Pharma. Drugs produced by companies that have the time and money to wade through all the FDA regulations to get official approval are better, safer, more effective. Supplements that may help you avoid the need for costly pharmaceuticals are not regulated, they don’t undergo the vigorous testing prescription drugs do and therefore should be avoided.

Let’s spin this another way: If it’s cheap and effective, maybe the FDA would prefer you didn’t trust it.

Consider this, “The FDA does not make drugs or directly test drugs to determine if they are safe and effective. The FDA’s role is to oversee the research conducted by pharmaceutical companies…” The results of the trials are obtained by the pharmaceutical company and given to the FDA.

Does this mean the prescriptions in your medicine cabinet don’t work? No…but it does mean they work only as well as the people who make them say they do.

Do you trust the FDA stamp of approval? I used to. Now I’m not so sure.

* Just a note on the other side of the argument. The Life Extension Foundation, authors of Life Extension Magazine, sells vitamins and supplements. Could their reports about the FDA be biased?


  1. I know two people who work in pharm. and they both live in fear of FDA audits -- not because they're trying to hide anything, but because the paperwork is so extensive. There's so much spent research money riding on the successful completion of an audit that the pressure to perform (on both sides) is astronomical.

    While I agree that those companies with deep enough pockets have a better chance of getting their product to market, I think the overall problem is that the checks and balances system doesn't work. (It's a theory I hold for every oversized checks and balances system.)

  2. That may definitely be the case. I do think there's bias on both sides - and again, it's hard for the average consumer to decide what's fact and what's fiction.