Arizona: Execution-drug import papers raise questions

3 shipments of drugs imported by the Arizona Department of Corrections were represented to U.S. customs and Food and Drug Administration officials as being for use on animals despite being intended for use in inmate executions.

According to documents obtained by The Arizona Republic under the federal Freedom of Information Act, 2 batches of the anesthetic sodium thiopental and 1 batch of the paralytic-drug pancuronium bromide were brought into the country from Britain last September and October and were described on federal import paperwork as being for "Animal (Food Producing)."

Thiopental, a painkiller, is used in executions to sedate the condemned convict, while pancuronium bromide renders the convict unable to move. A third drug, potassium chloride, is then injected to stop the heart.

The source of thiopental has been a matter of legal and political controversy in several U.S. states and European countries.

Defense attorneys have raised questions about whether the drugs were legally obtained and whether they were certain to be effective. Thiopental is meant to render an inmate unable to feel suffering during an execution. If the painkiller is ineffective, they attorneys argue, the execution could be cruel and unusual punishment.

Arizona has 2 executions scheduled during the next 2 weeks in which the drug is supposed to be used, although legal challenges are in the works.

State Corrections Director Charles Ryan said in a written statement that the department's execution drugs were "procured lawfully" and that the department in dealings with FDA and customs "clearly stated that the purpose for acquiring these chemicals was to carry out an execution."

It was not immediately clear whether the drugs obtained were, in fact, manufactured for animal use, or if the nature of the drugs was misstated in FDA documents.

"If FDA becomes aware of incorrect information in a filing, the agency has many options which could include further investigations and, where appropriate, pursuing civil or criminal sanctions," FDA spokeswoman Shelly Burgess said.

Thiopental is used for veterinary anesthesia but not for animal euthanasia.

Dr. Tom Doherty, a veterinary anesthesiologist in Knoxville, Ky., said, "You can mix it up in any strength you wish. But it wouldn't be used in (human) clinical use if it's labeled for animals. That wouldn't be allowed."

Burgess said federal approval of veterinary drugs takes other factors into account, such as whether the drugs are to be used on animals that are food-producing and calculating effects on the environment given that animals usually urinate and defecate on the ground.

"Animals are not equivalent to small humans. There are great species differences, and it's not always a matter of dose," Burgess said. "So, if a drug is approved for animals, it does not mean that it is safe to use in a human and vice versa."

Thiopental has been virtually unavailable in the U.S. since last summer and has not been manufactured domestically since 2009. That prompted several state governments to look to import it.

At first, the FDA officially said that there were no legal means of importing it. But late last December, after at least 5 states had obtained and used foreign drugs for executions, the agency reversed its policy and said it would not police drugs used for lethal injection.

Attorneys in several states have sued the FDA over that policy. Last week, the U.S. Drug Enforcement Administration seized a thiopental supply from Georgia to investigate whether it had been legally imported. This week, attorneys in Arizona and Kentucky asked U.S. Attorney General Eric Holder to investigate supplies in their states.

A recent report from Great Britain indicates that there have been 12 adverse reactions to British-produced thiopental. Lawyers in several states maintain that it may not have worked efficiently in recent executions, claiming that at least 3 men died with their eyes still partly open, suggesting they were not fully sedated before the other chemicals were administered.

Documents released to The Republic by U.S. Customs and Border Protection on Thursday show that the Arizona execution drugs - which were used last October to execute Jeffrey Landrigan and are expected to be used over the next two weeks to execute two more prisoners here - were labeled in import papers as drugs for use on animals.

The information was found on documents called "Form 701 Inquiry," an FDA document that must be filled out by the importer or import broker before the drug can pass through customs. On the documents, information that would identify the importer who filled out the form was redacted. Under federal statutes, filing false federal documents is a crime punishable by up to 5 years in prison.

The state Department of Corrections has consistently refused to discuss its execution drugs other than to say they were obtained lawfully. So far, state and federal courts have upheld that position.

Source: Arizona Republic, March 25, 2011

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