15
Jun
11

Peak antibiotics?

Megan McArdle has written what David Henderson calls her best post ever:

Briefly:

“Oh, shit” is an appropriate reaction here.  Megan explains:

  • Without antibiotics, there would be very little elective surgery.  Before sulfa drugs, surgery was a very serious business with a high risk that a patient might die of some complicating infection.
  • Without antibiotics, forget organ transplants.  The immune suppression would almost certainly be fatal in a pretty short time period.  HIV would also be more dangerous.
  • Without antibiotics, retirements would get shorter again. Before antibiotics, the average 60 year old who caught pneumonia was more likely than not to die of it than not.  That’s why they used to call pneumonia the “old man’s friend”. Nor is pneumonia the only potential killer.

That’s just the first three; the list gets much longer (go read her post, I can wait).

Now, that second graph looks like a bignormous beatstick with which to pummel the FDA, just begging for a libertarian to take it up and start swinging, doesn’t it?  “Overregulation in the FDA is artificially constraining the number of new antibiotics that make it to market!  Government involvement in health care killing people!  Death panels!”  Of course, things are a bit more nuanced than that, as Kevin Outterson notes:

Briefly, Outterson shows a slow decreasing trend for antiinfective drugs (including antiretroviral HIV treatments) and cardiovascular support drugs (with the caveat that we don’t need novel CV drugs the way we need novel antibiotics), and a rather steeper increase in approval rates for anti-cancer drugs.  The take-away point deals — you guessed it! — with incentives:

The big draw in cancer is reimbursement – paying tens of thousands of dollars for short course chemotherapy per patient will clearly get the attention of drug companies. My main point here is to consider reimbursement for antibiotics as a primary tool for both incentivizing new drugs and also supporting long-term conservation.

Of course, the incentives for developing new anti-cancer drugs aren’t just based on “tens of thousands of dollars for short-course chemo”.  As a quick look at the Avastin kerfuffle will tell you, cancer is scaaaaary to a lot of people in ways that, say, heart disease and MRSA aren’t.  Thus, the FDA’s under substantially more political pressure to approve cancer drugs (see Avastin again) than it is to approve new antibiotics — leaving aside the question of whether those new drugs actually work (see, yes, Avastin again).

That might seem like a pretty weak public-choice argument when compared to the “obvious” market failure story: antibiotics are relatively cheap per-dose, especially first-line antibiotics, which means teh ebil awful Pharma corpuh-ayshuns don’t want to develop them and instead do nasty things like develop, um, cancer drugs.  But for profit!  So it’s bad!  Outterson hints at this argument in his post — from an eminently reasonable direction, I should add, not the shrill caricature I’ve constructed above.  And the market-failure story might even be true, if we lived in a world where the market for pharmaceuticals wasn’t pathologically broken.

But, of course, we don’t.  You can see a lot of the broken-ness on public display at TIE if you’re a regular reader, but there’s more to it than that.  In particular:

Several drug shortages (e.g., concentrated morphine sulfate solution, levothyroxine injection) have been precipitated by actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative, which is designed to increase enforcement against drugs that lack FDA approval to be marketed in the United States. (These drugs are commonly called pre-1938 drugs, referring to their availability prior to passage of the Food, Drug, and Cosmetic Act of that year.) Some participants noted that the cost and complexity of completing a New Drug Application (NDA) for those unapproved drugs is a disincentive for entering or maintaining a market presence.

But the “FDA makes it too hard to get new drugs to market and is stifling innovation” canard’s pretty old by now.  How about we switch to a new one: the FDA imposes strict controls on how and how much of a drug is manufactured, making it essentially impossible to satisfy increased demand.  (It has that new canard smell and everything!)

The Federal Food and Drug Administration (FDA) has been stepping up its quality enforcement efforts — levying fines and forcing manufacturers to retool their facilities both here and abroad. Not only has this more rigorous regulatory oversight slowed down production, the FDA’s “zero tolerance” regime is forcing manufacturers to abide by rules that are rigid, inflexible and unforgiving. For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

(Emphasis added.)

Don’t tell me that’s not going to give pharma companies some big ol’ fucked up incentives.  I’m not prepared to argue that the apparently-looming shortage of effective antibiotics is solely due to overregulation like the above; I think the main component is simply that we’ve already found the easy ways to kill bacteria, and have been using them for long enough that bacteria are evolving to counter them.  In other words, we’ve eaten all the low-hanging fruit.  But with that said, I don’t see how it’s possible to argue credibly that zero-tolerance production quotas aren’t making the problem worse.

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4 Responses to “Peak antibiotics?”


  1. June 20, 2011 at 23:03

    Another way the system is broken is that non-patent antibiotics are obscenely cheap and easy to acquire. If I want to dose my cows or my chickens or my pigs or my fish or my dogs – or even myself – with cheap over-the-counter amoxicillin, tetracycline, cephalexin, ciprofloxacin, metronidazole or sulfamethoxazole I just need to find an over-the-counter veterinary formula, look up the proper dosage and have the balls to use it.

    And the fact that many producers have discovered that cheap OTC antibiotics are a cost-effective way to control diseases spread by poor sanitation – means that we have a system that may as well have been designed to create antibiotic resistant bugs.

    • June 20, 2011 at 23:07

      I need to throw together a big flashing red block-caps “EXTERNALITY” animated gif, just for situations like these.

      It makes me throw up a little in my mouth just to type it, but maybe we need a big ol’ Pigovian surtax on OTC antibiotics.

  2. June 21, 2011 at 17:48

    Some government control is a good thing. Drinking water standards, surface and groundwater discharge controls, licensing for doctors and engineers.

    And upon a little thought I believe I’d much rather see strict taxes / controls on antibiotic drugs than the psychoactive ones. ‘Cause heck, as long as I’m not driving a car or something the only person I’ll hurt if I choose to abuse pot or cocaine is myself. If I choose to abuse antibiotics I’m screwing with the entire freaking ecosystem.


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