This week we’ve seen a striking example of government innumeracy that has a good chance of badly affecting government policy.
The Food and Drug Administration wants manufacturers to package their medications in smaller quantities, such as eight tablets per package. Currently, some generic versions are sold in boxes of up to 200 tablets. The FDA said it also plans to ask online retailers to make it harder to order bulk amounts of the drugs.
The key ingredient in anti-diarrhea medications like Imodium is part of the opioid family, an addictive drug class that includes morphine and oxycodone. At low doses, the medicine, known generically as loperamide, helps control diarrhea. But recent statistics show a rise in abuse of the drug, including massive doses that can cause heart problems and death.
This is from Matthew Perrone, “The FDA Is Cracking Down on Imodium and Other Anti-Diarrhea Medicine Because of the Opioid Epidemic,” Time, January 31, 2018.
And how dangerous are these medications?
Fifteen deaths were tied to the drug between 2010 and 2016, researchers reported in a study last year.
In short, 2.5 deaths a year and, to respond to that, the feds want it to make it more costly in time and money for everyone to get Imodium and similar drugs.
To put that one death a year in perspective, it is 5% of the number of Americans killed in a typical year by lightning.
This one death a year also appears to be an overestimate, according to Josh Bloom. In “Runs On Imodium Before The FDA Clamps Down,” American Council on Science and Health, January 30, 2018, Bloom reports some facts and does his own numeracy analysis:
So, this stuff must be a bubonic plague-like killer, right? Not so much:
“In the 39 years from when loperamide was first approved in 1976 through 2015, FDA received reports of 48 cases of serious heart problems associated with use of loperamide…Thirty-one of these cases resulted in hospitalizations, and 10 patients died.”
Source: FDA
THIS is what all the hysteria is about? This comes to 1.23 cases per year of serious heart problems and 0.25 deaths associated with the use of loperamide. This means there is 1 death annually per 1.1 billion people in the US. One death every 4 years. Here are some comparable death risks.
Death from being hit by a falling coconut (1 in 250 million)
Death from a shark attack (1 in 300 million)
Death from a roller coaster accident (1 in 300 million)
Since every non-problem has a non-solution it should not be surprising that some want the drug behind the counter – an increasingly crowded place.
For more on various small risks, see Aaron Wildavsky and Adam Wildavsky, “Risk and Safety,” in The Concise Encyclopedia of Economics.
HT2 Jeffrey A. Singer
READER COMMENTS
JFA
Feb 1 2018 at 3:33pm
Minor comment that won’t change the thrust of the post: 15 deaths between 2010 and 2016 would be about 2 deaths a year, not 1 (you might have misread it as 2001).
Also, that title “Runs on imodium…”: absolutely hilarious.
Thomas Boyle
Feb 1 2018 at 4:01pm
If the FDA has resources to expend on risks this low, is it fair to say it could take substantial funding reductions without any meaningful impact on public health?
gwern
Feb 1 2018 at 4:07pm
The worst part is, if imodium abuse by addicts trying to avoid heroin is a real problem at all, it’s only because of all the well-intentioned but disastrous government regulations put on the standard heroin addiction treatments like methadone before!
David R Henderson
Feb 1 2018 at 5:30pm
@JFA,
Quite right. You even figured out that I misread it as 2001. Change made. Thanks.
@Thomas Boyle,
If the FDA has resources to expend on risks this low, is it fair to say it could take substantial funding reductions without any meaningful impact on public health?
I think so. You would have to make sure that the right things are cut. If you took people off the drug approval process, for example, it could go either way. Maybe those people were slowing it down, like the famous case of the FDA employee who, when the speed limit was 55, drove 55 in the fast lane to slow people down and acted that way at work too. Or maybe those people were speeding it up. Both types exist at the FDA.
@gwern,
Good point.
Phil
Feb 1 2018 at 6:21pm
I am fairly well educated and did not know that Immodium is in the opioid family. I wonder how many opioid addicts knew that. The publicity generated by this silly regulation quite possibly did more harm than good by presenting to addicts an otherwise unknown alternative.
FDA: lead us not into temptation.
Thomas Boyle
Feb 2 2018 at 7:35am
@David Henderson,
The idea is not so much to adjust the budget at the margin, as it is to use the budget adjustment to change the incentives the FDA faces.
If the organization found itself having to defend why it is able to spare resources for such low-value purposes, it might indeed make sure it reallocates its resources to higher-value purposes.
Incentives matter, even in government.
Alan Goldhammer
Feb 2 2018 at 9:09am
One problem with David’s post is that we really don’t know the full measure of loperamide abuse. Adverse drug reporting for OTC products is really quite poor.
I believe that loperamide (either the branded product Imodium or the store brands) are already packaged in blister packages as they are in Europe and these come in dose limited packs (we forgot to pack some when we went to England and Ireland last summer and bought a pack of 12 caplets in Dublin which is the standard dispensing amount). It should also be noted that in most of Europe, most Rx pharmaceuticals are packaged in unit of use packaging and not in large bottles of a 1000 pills.
“If” there is an abuse issue with loperamide it might be moved to behind the counter in the same way products containing pseudoephedrine are. I would also not that far more fatalities and hospitalizations result from acetominophne (Tylenol) poisoning than loperamide or any other OTC drug yet the US continues to have it as an OTC product where most of Europe has moved it behind the counter.
Terry Ott
Feb 2 2018 at 11:56pm
On this Imodium subject, I foresee potential unintended consequences of making it more difficult to obtain and, thus, less likely to be used.
More uncontrolled diarrhea means more toilet flushing and more use of toilet paper. To a hard core environmental activist that would sound alarm bells re: water usage, and deforestation. I fully expect the environmental lobby to articulate arguments galore to beat back the imodium prohibitionists.
p.s. I loved the book “Innumeracy” (John Allen Paulos).
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