Drug Labelling

I got into a Facebook debate last night with some very smart, well-informed, and well-meaning individuals… but I think they are completely wrong. The trigger event was the FDA voting to remove certain formulations of painkillers from the pharmacy. Here’s the link: http://t.co/19CmGb4y.

I understand liver failure due to acetaminophen toxicity, and I think it’s a darned shame that it kills 200 people per year. Of course, half of those are intentional suicides who would find another way to die… and, remember, doctors kill fifty times as many patients a year with bad handwriting. Never mind. I commented:

I realize I have a minority opinion. (Nothing to do with the toxicity of acetaminophen… I simply reject the entire premise that the FDA should have the authority to regulate what is sold to American citizens. Once again we’ve chosen to trade freedom for the illusion of security. C’est la guerre.)

One commenter replied:

Anti-regulation libertarianism assumes an informed and active consumer, and the diabetes epidemic proves that you don’t have that in the real world – libertarianism is based on even more magical thinking than communism. I work in this space, run companies in this space, and trust me please – you wouldn’t want to give up the FDA. You certainly wouldn’t want your loved ones in a hospital if they weren’t doing their job (imperfectly, yes, this is the real world).

I confess to being a rational libertarian — not an anarchist, and not a disciple of the Ayn Rand cult. But I do think that, in most cases, adults should be allowed to make their own decisions as long as they don’t hurt others. That includes drugs. Prescription drugs. Non-prescription drugs (tried to buy Sudafed lately?). Megadoses of Vitamin C. Alcohol. Nicotine. Peach pits from Mexico. And the whole phylum of illegal drugs that I’ve never tried, don’t want to try, but which don’t seem to be destroying Amsterdam nor Portugal at the moment. Rack ’em all up behind the counter, convince the pharmacist that you’re rational and have the cash, and walk away with a bag of whatever you want.

It’s just like I tweeted at the TEDMED conference two weeks ago when the Commissioner for Food and Drugs was on stage:

That doesn’t mean the FDA should be abolished… in fact, I’d increase their budget to speed up the testing of drugs and medical devices. But I would take away their police power to determine what may or may not be sold to adult citizens who haven’t been declared wards of the state.

What I would do is print a whole bunch of stickers, and enforce a law that anything that looks, smells, or is advertised to be even in the same neighborhood as a medical treatment should have one of these stickers. (See? I’m really NOT an anarchist!)

Black Label

First sticker: We’ve tested this stuff, and it will kill you. If you take it, you’re a damned fool. Hope your affairs are in order. Bye.

Red Label

Second sticker: STOP. We haven’t tested it and have no idea what’s in it. Could be anything from arsenic to angelhair pasta. Unless you have done your homework, taking this probably makes you as big a damned fool as someone taking the black label brew.

But anything — anything! — could be put on the shelves with a red label with no laboratory testing. That includes products from ethical pharmaceutical houses who are working through their billion-dollar FDA clinical trials (objective: green label), but want to make the product available early under red label.

Orange Label

Now things get interesting. The orange label is roughly consistent with completing today’s Phase I clinical trial. The product isn’t poison (at least at recommended dosages) and it doesn’t do any obvious damage.

Put it on the shelves with a big orange question mark, and the FDA should put all its data online for analysis and summation by the WebMD’s of the world. Maybe this is good for you, maybe it’s not, but some drug developers may choose to pause their clinical trials at this stage and not incur the Phase II/III costs until they get market feedback.

And, given what we know now, acetaminophen would likely get an orange label.

I could see an entire class of “orange-label” venture investors emerging… they provide enough capital to get to orange-label, start selling the product… and if a green-label company wants to scoop them up for a few hundred million dollars then invest a few hundred million more in a successful Phase III trial… well, that’s a nice exit, too.

Green Label

Green label: this is the good one! This signifies that the drug has met the same standards as a Pre Market Approval (PMA) after undergoing successful Phase I/II/III trials (many years and many millions of dollars).

Ethical pharma companies will still pursue this label for their blockbuster drugs since they can charge whatever the market will bear to those patients who will only take green-label drugs. (And there will be a lot of those patients!)

If you don’t like this proposal, you could choose to be unaffected by it. Only buy green-label drugs, and you have the same level of nanny-state oversight and “safety” that you have now. (We won’t mention Vioxx.) Maybe you’ll choose to go to a hospital that only provides green-label drugs. Maybe your health plan only reimburses for green-label.

If you’re willing to do a little more digging yourself, and finding trustworthy sources, and weighing the risks, it’s not hard to see you taking an orange-label medication sometimes.

A smaller fraction will take red-label. And only the terminally-ill (including, sadly, the terminally mentally ill) would ever take black-label… either as a suicide pill, or in a last-ditch effort to kill a cancer or equivalent condition before it kills him.

Through the entire process, individuals (who are over 18 and not wards of the state) are allowed to make their own decisions. Some will make bad decisions. Some will die from those bad decisions.

Think of it as evolution in action.

And are those deaths any worse than the 10,000 Americans who die of bad handwriting per year… where the fix is so simple as to be laughable? Be careful criticizing the mote in my eye when you have a whole damn tree lodged in yours…


  1. jhpincus says:

    The difference between the categories you defined is nnot usually as clearly demarked as you indicate. Drug safety may vary between individuals depending on their genetic makeup, past history of illneses, and ohter factors. The difference between safety and toxicity may be very small and subject to factors thatonly trained individuals can identify or predict.