Friday, 11 October 2013

EUROPE-U.S.: The Propofol's Controversy

The possibility that a common anesthesia drug may soon be used in the United States to execute death-row inmates is causing problems for European pharmaceutical companies. They worry the European Union may soon impose sanctions.

The compound Propofol has long been the most popular anesthetic drug in the United States, with some 50 million doses administered in the country's hospitals and other medical facilities every year. But plans by several US states to begin using the drug for executions have drawn wide concern in the European Union, where near 90 percent of the Propofol supplied to America is manufactured.

Now, out of concern that EU regulations will result in severe restrictions on the drug's export, the advocacy groups in the US are scrambling to prevent the drug from being used for lethal injections.

The state of Missouri announced on Wednesday it would send back a shipment of Propofol it had planned to use for executions after the European Union manufacturer voiced concern. Fresenius Kabi, by far the largest supplier of Propofol to the US, instructed its distributors last August not to ship the drug to any departments of corrections in the country after several states said they planned to use it for lethal injection. But the Louisiana-based distribution company, Morris & Dickson LLC, sent the shipment to the Missouri Department of Corrections by mistake.

The Propofol, if used for executions, could be placed on the EU's list of export restricted substances under the so-called Torture Regulation, which would then severely restrict US access to the popular drug. Capital punishment is illegal throughout the EU. Were Propofol to be classified under the Torture Regulation, it would mean layers of added bureaucracy and three to six month waiting periods for every shipment. Any executions with Propofol would lead to an extreme shortage.

A spokesperson for Catherine Ashton, the EU's high representative for foreign affairs says that officials in Brussels continue to monitor the situation and that the bloc is conducting an on-going review which is in its final phases. If the review results in Propofol being classified under the Torture Regulation, European Union manufacturers will need to apply export controls in order to supply US hospitals.

The Missouri Department of Corrections said Wednesday in a press release that it still retains a supply of domestically manufactured Propofol. Missouri Governor Jay Nixon said earlier in the week that the state would go forward with two planned executions, currently scheduled for Oct. 23 and Nov. 20.

Nixon went on to say that American court systems, not European politicians, would dictate death penalty policy in Missouri. The executions would be the first to use Propofol. Although Missouri has returned drugs, It could still lead to a restriction of Propofol, even if they were to use drugs received from other sources ... From an EU regulatory standpoint, there is no distinction made between Propofol being used for therapeutic purposes and that being used to execute people.

The Missouri Correctional Department's decision to return the shipment of Propofol comes a day after it responded to an open records request and subsequent law suit filed on Oct. 4 by the American Civil Liberties Union.

One of the documents released by Missouri to the ACLU and now made public contains an email sent on Nov. 2 from the distributor to Missouri Corrections Department Director George Lombardi in which he says that "a system failure that inadvertently allowed" the drug to be sent to Missouri had caused the manufacturer to suspend its business with the company. "Please -- please -- please HELP," the email continues. "This system failure -- a mistake -- 1 carton of 20 vials -- is going to affect thousands of Americans."

Both the Food and Drug Administration and the Missouri Society of Anesthesiologists have also voiced concern over the state's use of Propofol for lethal injection. And a pending lawsuit filed on behalf of 21 death-row inmates argues that injection of the drug constitutes cruel and unusual punishment.
Propofol is the most popular anesthetic drug in the US, used in a variety of surgical procedures in some 15,000 hospitals and clinics. It came to public attention in 2009, when it was blamed for the death of American pop star Michael Jackson.

US states have been searching for alternative sources for lethal injection drugs over the past couple years, as tighter European export controls have led to many pharmaceutical firms banning distribution for executions.

By Jennifer Birich
AFP's blogger

Photo-Credit: Reuters