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How Poorly Regulated Drugs Could Be Leading To Cruel And Unusual Executions

By Nicole Flatow  

"How Poorly Regulated Drugs Could Be Leading To Cruel And Unusual Executions"

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Texas Death Chamber

During the 2012 execution of Eric Robert in South Dakota, witnesses reported watching him turn purple, gasp heavily, and snore for 20 minutes before the state declared him dead. In January of this year, Michael Lee Wilson was heard to cry out “I feel my whole body burning” before he died by execution in Oklahoma.

Both of these deaths were carried out using a small-batch barbituate made by a pharmacy not regulated by the Food and Drug Administration. And a pharmacist supporting a lawsuit to block use of these drugs say these symptoms are consistent with contaminated pentobarbital, which could cause severe pain and suffering during execution.

Another recent execution that generated particular public attention last month also used small-batch drugs made by a pharmacy not regulated by the FDA, according to the lawsuit. The execution of Dennis McGuire took a record 24 minutes, as he snorted, gasped, and convulsed.

The controversial pharmacies that produce these drugs without federal oversight are known as “compounding pharmacies.” States have started to turn to these drug-makers after international drug companies refused to provide their drugs for use in the death penalty, citing their moral opposition to the practice. But an affidavit from pharmacist Larry D. Sasich suggests that worries of inconsistent manufacture by these pharmacies are well-founded, citing these recent executions.

“The production of injectable pentobarbital sodium, or other drugs, starting with a non-sterile Active Pharmaceutical Ingredient (API) is technologically too difficult to do outside of FDA-regulated facilities that must comply with federal GMP guidelines,” he said in an affidavit.

Sasich is providing expert opinion in the latest lawsuit challenging these drugs. Last month, a lawsuit on this issue failed to block the Missouri execution of Herbert Smulls. Missouri refused even to disclose the name of the compounding pharmacy that manufactures the execution drugs, meaning a plaintiff’s lawyers have no means of verifying whether the drugs were made properly. But a federal judge sided with the state.

Now, Sasich says he knows the identity of the pharmacy that manufactured the drug for Smulls’ execution, and says the procedures they used did not meet basic standards. Among other things, he says, testing of the drug from the Apothecary Shoppe revealed an “unknown solvent” that was never identified. “It is unacceptable by any standard to inject an unknown substance into a human subject,” Sasich said in his affidavit.

What’s more, he wrote, “The failure to properly store the pentobarbital intended for use in executions creates a very substantial, even grave, risk that the prisoner will suffer severe pain and/or an immediate severe allergic reaction.”

This week, an Oklahoma judge agreed to temporarily block the sale of another batch of drugs from this pharmacy for executions in Missouri, finding the plaintiffs were reasonably likely to succeed in their claim that such a lethal injection could amount to cruel and unusual punishment, and violates federal law because the drug would travel from one state to another.

Even as the lawsuit claims that the Apothecary Shoppe has been responsible for these recent executions, both the state and the pharmacy have declined to confirm whether this is true. The state claims the pharmacy might not agree to provide the drug if its identity was known. Use of secret, under-regulated drugs is one of several controversial methods states are considering to continue executions in the face of a drug shortage. Other states are considering a revival of the gas chamber, electric chair, and firing squads.

Update

The Apothecary Shoppe has agreed not to supply drugs to Missouri for Michael Taylor’s lethal injection, the Associated Press reports. In a legal filing Monday, it asked the judge to drop the lawsuit, saying it had not yet provided the drug to Missouri for Taylor’s execution. If this lawsuit is settled or dismissed, Missouri will avert a judicial ruling on whether it can buy non-FDA-regulated drugs from other states.

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