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September 28, 2013

Could execution drug difficulties and switches result in real public health problems?

The question in the title of this post is prompted by this AP article, headlined "Use of drug for execution might cut supply: Missouri plans on using common anesthetic in October to kill convicted murderer." Here are excerpts:

The planned use of a common anesthetic in a Missouri execution is raising concerns that the anti-death penalty European Union could limit export of the drug, endangering the supply of a vital medication used every day in thousands of American hospitals and clinics.

The execution scheduled for Oct. 23 would be the first to use propofol, which is by far the nation’s most popular anesthetic. About 50 million vials are administered annually in some 15,000 locations.  That’s about four-fifths of all anesthetic procedures, according to the American Society of Anesthesiologists.  Propofol is popular because it works quickly and patients wake up faster with fewer side effects such as post-operative nausea.

Roughly 85 percent of the U.S. supply of propofol is made in Europe, where capital punishment is outlawed, by the German company Fresenius Kabi.  Export is controlled by the European Union, which prohibits trade in goods that could be used for executions.  The EU is reviewing whether to subject propofol to that rule.

If it is added to the regulation, propofol would be subject to export controls, not a complete ban, EU spokeswoman Maja Kocijancic said. Still, any change in export practices could have a drastic effect on propofol’s availability in the U.S., said Matt Kuhn, a spokesman for Fresenius Kabi USA. “It’s a real concern,” Kuhn said Friday. “And it could have enormous public health implications.”

Fresenius Kabi has launched a website specifically to address the ramifications of using propofol in a U.S. execution, http://propofol-info.com. The Food and Drug Administration is worried about any move that could affect access to propofol. FDA spokeswoman Erica Jefferson said the agency is weighing how to reach out to European officials to ensure the drug remains readily available. “We do consider this a critical need,” Jefferson said. “Without the drug, we’re concerned that surgeries would be delayed and patients would be at risk.”

Until recently, Missouri and other states with the death penalty used virtually the same three-drug protocol. That changed in recent years as drug makers stopped selling the traditional execution drugs to prison officials because they didn’t want them used for lethal injections.

Last year, the Missouri Department of Corrections turned to propofol, which made headlines in 2009 when pop star Michael Jackson died after overdosing on the drug. So far, Missouri is the only state to adopt propofol for executions, though it has not yet put anyone to death with the drug.

At one point, the shortage of execution drugs was so concerning in the state that Attorney General Chris Koster hinted that use of the gas chamber was a possible alternative. Missouri used gas for executions in the early 1900s but no longer has a working chamber.

September 28, 2013 at 10:37 AM | Permalink

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Comments

How ironic for our friends in Europe to want to cut off the supply of a drug overwhelmingly (like 99.99%) used for pain-blocking anesthesia -- all in the name of humanity!

Far out!!!

P.S. Of course the actual prospect of their doing any such thing is minimal. But we can never get enough of anti-DP speculation, now can we?

Posted by: Bill Otis | Sep 28, 2013 12:22:14 PM

The DOJ has extorted billions of dollars from pharmaceutical companies for knowingly distributing a drug for "unapproved" uses of it.

Unless you can show me an FDA approved label for the administration and dose of propofol for "ending one's life", I am with the European Gubermints on this one.

As ALWAYS, a government agency wants to have its cake and to eat it too.

Posted by: albeed | Sep 28, 2013 7:53:10 PM

PS:

I should have added "Far out" before the last sentence in the preceding post.

Posted by: albeed | Sep 28, 2013 7:56:22 PM

Albeed: The FDA's mission came from a 100 year old law to regulate treatment and food.

This is not a treatment. It is a poison, subject to regulation by the EPA or the Department of Agriculture.

Why is that so hard for the lawyer to understand? As such, these chemicals can be mass produced by prison industries. It may serve to open a new business for them as well, the generic drug business, for much higher fees, than they collect now.

Posted by: Supremacy Claus | Sep 28, 2013 8:05:07 PM

SC:

Don't challenge me on drug histroy sine the 1908 Pure Food and Drug Act. However, I agree with you in essence.

Anybody can make this compound and use it anyway they want. Let the government do its own dirtywork, and by that I don't mean not executing people who have done great harm to others.

But to insist that a pharmacutical company willingly supply a drug for an unapproved use is a Catch 22 that they cannot win.

Posted by: albeed | Sep 28, 2013 8:17:34 PM

PS:

A typo in the previous post should have said 1906 Pure Food and Drug Act

Posted by: albeed | Sep 28, 2013 8:20:31 PM

albeed --

Congratulations on approving the actions of some government, somewhere, even if it's only "European Gubermints."

So I won't quibble merely because the EU isn't exactly a "Gubermint." Close enough, I guess.

At this rate, you might even approve the US Gubermint's decision to declare war on Germany back in the Forties -- not that I want to count on anything prematurely, mind you.

Posted by: Bill Otis | Sep 28, 2013 8:44:06 PM

Umm, there is nothing wrong with off label use as such, the only thing the manufacturer gets in trouble over is promoting off label uses (which certainly does not appear to be anywhere near the case here). Manufacturers are even supposed to be able to supply truthful information regarding off label uses, but as I understand it that line is close enough to FDA's current idea of promotion that mos drug makers won't.

There are even plenty of instances where an off label use of a drug is the standard of care for particular conditions.

Posted by: Soronel Haetir | Sep 28, 2013 11:46:16 PM

Albeed: Not challenging on history or knowledge. On jurisdiction.

One possible explanation for the lawyer's blindness to the self evident? They are dumbasses, mentally crippled by the law education. Example, a Harvard Law Grad with a PhD in Medieval English Legal history did not know what I learned in 10th Grade World History and Western Civ 101, the meaning of the word, reason, in Scholasticism, and why it has to be the central doctrine of the common law, according to St. Thomas, and his student Henry of Bratton.

The latter wrote the Notebook, and we practice his law unchanged in any fundamental way. Couple of problems. A monk (violating the Establishment Clause). French (Bratton is Brittany). Judge for Edward the I, Longshanks. Explained sovereign Immunity by saying the King, tyrant Ed, spoke with the voice of God. (Cuckoo, cuckoo).

Mr. Harvard likely had twice my IQ entering the education. Now, MR special ed students have more common sense about justice than he does.

Posted by: Supremacy Claus | Sep 28, 2013 11:46:45 PM

Mr. Bill: How ironic for our friends in Europe to want to cut off the supply of a drug overwhelmingly (like 99.99%) used for pain-blocking anesthesia -- all in the name of humanity!

In the name of the law. Some people think the law should not be violated for personal/politcal reasons. What do you think of that?

Posted by: George | Sep 29, 2013 12:41:47 AM

Stop injecting poison into blood.
Start removing blood from condemned.

Posted by: Just Plain Jim | Sep 29, 2013 5:15:50 AM

George --

I think that foreign "law" (the USA is not a signatory to the EU) is, on American soil, subordinate to the orders of American courts.

If a foreign court ordered the genital mutilation of one of its nationals visiting the USA, do you think our law should bow to that? Or would the contrary order of an American court trump the foreign law?

Posted by: Bill Otis | Sep 29, 2013 10:04:48 AM

Mr. Bill, "Roughly 85 percent of the U.S. supply of propofol is made in Europe...."

That makes your reply at most 15% relevant since we don't know if the other countries have laws against exporting to DP countries. So should the European Union respect its own laws or should you fight to change them, as you usually argue.

Posted by: George | Sep 29, 2013 3:42:49 PM

One question for any trade/business law experts who might visit this site? Does the EU regulation restricting the export of any drug/chemical that might be used in a legally-authorized execution violate the World Trade Agreement?

Posted by: tmm | Sep 30, 2013 10:20:15 AM

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