You don't ban cars because people drive them off cliffs, part 2

Back in 2009, I wrote that the FDA was considering banning prescription painkillers such as Vicodin and Percocet, on the grounds that they contain acetaminophen, a common over-the-counter drug that can cause liver damage if taken at too high a dosage. Especially as patients become inured to the effects of the opioid portion of such painkillers, they end up more likely to take more of them and thus expose themselves to life-threatening doses of acetaminophen.

As I argued then, the government doesn't ban cars just because some idiots drive cars off cliffs; it doesn't ban pencils because pencils can be shoved into the eye; and it has no business banning a painkiller just because some patients don't know how to use it correctly.

The FDA has decided not to flat-out ban these opioid medicines, but it HAS now ordered the makers of opioid/acetaminophen combinations to find a way, within three years, to reduce the amount of acetaminophen in their pills below a prespecified amount, or else pull the products from the market.

Sounds easy, right? Why should something as simple as cutting the dose of one component of a pill take three years to accomplish?

Because the FDA won't accept drug manufacturers doing just that, that's why. Not without the manufacturers performing studies to show that the new formulations are just as effective as the old ones, that they don't present additional potential for addiction, and that they're safer. So the manufacturers of Vicodin and Percocet will have to spend all kinds of money -- money that they could have spent on research and development of innovative new drugs -- just to prove that something that already works deserves to stay on the market.

And all this money will be spent to force pharmaceutical companies to take responsibility for patients who weren't responsible enough to learn about the risks of something they're putting in their own bodies. Huh?!

Here's how this would work in a free market: If a substantial number of people were getting liver damage and dying because of Vicodin and Percocet, patients and doctors would start avoiding the drugs and demanding new, lower-acetaminophen options, giving pharmaceutical companies an incentive to offer those options. The drug companies wouldn't have to prove to a government agency that opioid drugs work on their own or with lower doses of acetaminophen, so patients could have those drugs right away. And patients and doctors would have an incentive to ask questions -- Is this drug safe? Are there other drugs I should avoid taking when I'm taking this drug? How much of this drug can I safely take? Instead, we have a nanny state holding back new options and trying to make drug companies responsible for protecting patients instead of allowing patients to protect themselves.