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The above headline appeared Feb. 4, 2011, on www.pharmalot.com. It was written by excellent investigative reporter Ed Silverman. Additional information comes from a New York Times article published on Jan. 25, 2011.
On Feb. 3, 2011, six prisoners on death row in Arizona, California and Tennessee filed a lawsuit claiming that the Food and Drug Administration (FDA) had violated federal law by allowing the states to import the barbiturate sodium thiopental, despite the absence of any official...
The above headline appeared Feb. 4, 2011, on www.pharmalot.com. It was written by excellent investigative reporter Ed Silverman. Additional information comes from a New York Times article published on Jan. 25, 2011.
On Feb. 3, 2011, six prisoners on death row in Arizona, California and Tennessee filed a lawsuit claiming that the Food and Drug Administration (FDA) had violated federal law by allowing the states to import the barbiturate sodium thiopental, despite the absence of any official review for its safety and effectiveness.
The injection of sodium thiopental is the first step in lethal injections for prisoners on death row. It causes prisoners to lose consciousness before the second and third drugs paralyze all muscles and then stop the heart.
In 2009, the last remaining U.S. producer of the sodium thiopental, Hospira, stopped making the drug. The prisons in some of the 34 states that used the drug began to seek it from other sources outside the U.S.
According to Pharmalot:
Last month, the FDA decided to permit imports, but declined to vouch for the meds, even though one recent execution may have involved an expired import. “Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA’s explicit public health role,” the agency stated. The “FDA does not verify the identity, potency, safety, or effectiveness of substances imported for this purpose.”
The FDA decision has caused a firestorm. In some countries, such as Italy, Germany and the U.K., there have been calls for their domestic drug makers to decline export orders to the U.S. if the meds are to be used for capital punishment. For their part, the U.S. inmates charge the FDA has acted “arbitrarily, capriciously and has abused its discretion” for failing to review imported thiopental and, therefore, is acting “contrary to the public health.”
The most poignant reader comment on the Pharmalot website in response to this article was: “Hey! What about a more radical idea? Let’s just stop executions!”
Most physicians, I would assume, oppose capital punishment. When the FDA approves of a drug, the underlying assumption needs to be that the benefits outweigh the risks, a balance that needs to be determined at the patient level. The agency is therefore correct to avoid an implicit endorsement of state-authorized lethal injections.
