The FDA, the U. S. Food & Drug Administration, has one thing in common with the pharmaceutical industry: They don’t don’t think the average citizen is too bright. Maybe more to the point, they think America’s physicians lack common sense or integrity or both.

They have this thing called “fair balance.” Simplistically, it says that when it comes to food and drugs, but especially drugs, you can’t only tell the people the good stuff, you must present a balance – here are the good aspects, here are the bad. Where your intelligence gets insulted is that the whole dynamic is based on the assumption that you wouldn’t have been smart enough to pursue this balance on your own. That you can’t be trusted with the keys to your own life because you haven’t the capacity to ask questions and that you’re too thick to engage in critical thinking – essentially, the FDA believes you’ll just swallow any pill a stranger hands you.

So you and I are gullible, we need to be protected from ourselves, but the FDA apparently thinks even worse things about doctors. We simply should not need a federal agency to be the arbiters of “fair balance.” That’s what doctors are for, right? Only crackheads and stoners (and Libertarians) take medication without a prescription right? The rest of us are under a doctor’s care, we get sick, go to the doctor, he gives us a prescription and a treatment regime and right there, in person, like human beings, the doctor gives us “fair balance.” Pat, this should fix you up, but be on the lookout for BLANK, and if BLANK happens, stop taking it.

But okay, let’s assume that life is better safe than sorry and that the FDA is just worrying about my well-being and not trying to control my life or perpetuate a bureaucracy where its employees get kickbacks from Big Pharma so that everyone who works there can have a house in the Hamptons. Even with those assumptions, it’s still not fair or balanced. Pharmaceutical companies are so terrified of the FDA – in many cases rightfully so since an unfavorable letter from the FDA can derail clinical trials – that they feel they have to make the warnings and the potential side effects the whole story. In print advertisements and on websites, finding the product benefit, the reason this drug or treatment might help, is like trying to find Lake Tahoe on a map of the United States. (Oh, I found it, there’s Fredo and Al Neri out on the boat!)

TV commercials are even worse, and if you don’t believe me watch an hour of the Hallmark Channel some night. The Hallmark Channel’s target demographic is sixty years of age and older; many, many nice older ladies. Anyway, these old gals seem to have an unfair number of life’s serious maladies. Most of the things that cause you to hack up phlegm or lead to skin blotches or walking with a limp or that involve adult diapers, well, these gals have them. This is why they watch this station because it only serves up unrealistic, far-fetched, romantic, made-for-TV dramas that end with a kiss, and this is also why pharma companies line up around the clock to air their drug commercials here.

These spots are formulaic and they happen one after another, after another, and if you watch any one of them in their entirety, word for word, you’d be scared shitless. I recently saw a new one about type 2 diabetes, and then I went online and watched it a few more times. It was ninety seconds long. More than two-thirds of the total running time addressed background information and side effects; twice as much time was dedicated to how this drug might cause harm than how it might help, even though we know that many of the side effects and bleak occurrences are rare.

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Somewhere along the line, I sat through a presentation about the drug approval process mandated by the FDA.  The FDA drug approval process has four phases from “preclinical” to “phase III,” a process that typically takes ten to fifteen years and a cash outlay that can be in the billions. We were told that for every 5,000 compounds that enter the FDA pipeline, only ONE can be expected to win approval – that’s 1 in 5,000! Big Pharma often uses the government drug approval process as a key reason why drug prices are so high and it’s not an unreasonable claim. They say the price of a pharmaceutical product isn’t just a factor of the cost of making that drug today, but rather it’s that cost PLUS a prorated percentage of the billions of dollars that had to be invested to get it approved.

The FDA is like a timid little child, so afraid of making a mistake, so fearful of litigation and public blowback that instead of aiming for greatness and taking reasonable chances, they essentially say “no” to everything and take no chances at all. This kind of caution isn’t necessarily bad unless of course you’re sick and you don’t have the luxury of time. So nothing’s fair and balanced and the FDA is disincentivized to pursue meaningful pharmaceutical breakthroughs, which begs the question, Who should be responsible for balancing the risk-reward in your life, you or the government?

We’re all smart enough to find our own fair balance and we don’t do our medical research on the Hallmark Channel.