The U.S. is facing a shortage of a drug widely used for lethal injections. With few options, states are turning to new drugs and compounding pharmacies, rather than overseas companies.

The move is raising safety concerns, and in some cases delaying executions. Other executions are proceeding, however, and advocates are asking whether the use of new drugs violates the inmates' Eighth Amendment protection from cruel and unusual punishment.

A Witness To Lethal Injection

In 1989, William Happ was sentenced to death for the murder and rape of 21-year-old Angie Crowley. For decades, Happ appealed and lost.

His death sentence remained, but the method of execution had changed since his conviction. Since 1924, Florida had used the electric chair to execute prisoners, but in 2000, facing pressure from the Supreme Court, the state switched to lethal injection.

More than a quarter century after Crowley's murder, Happ's execution date was finally set for Oct. 15, 2013. But the state had a problem: Supplies of pentobarbital, a drug commonly used for executions, were running low. As the execution date approached, the state ran out of the drug altogether.

So the Florida Department of Corrections decided to use a new drug — a sedative called midazolam that had never been tested for execution. Nobody knew exactly how it would work.

Associated Press reporter Brendan Farrington was in the viewing room. "It's a very solemn, serious, quiet atmosphere. There's no talking," he tells All Things Considered host Arun Rath.

"They bring the witnesses in, and there's a screen across a long, rectangular window. And when they're ready to begin, the screen slowly rises," Farrington says. "The person conducting the execution will announce that the sentence is about to be carried out, tells this to the condemned, and asks if he has any last words."

Happ chose to speak, admitting to the crime and expressing shame for it. "[He said] he hopes God forgives him, and he realizes the family probably could not," Farrington says. "From there, the execution proceeds."

At 6 p.m. sharp, the execution began. Farrington had seen three other executions, none of which used midazolam. In those cases, he says, the prisoners' eyes closed "fairly quickly, and once their eyes closed, they usually stay closed."

"While it wasn't dramatically different than previous executions, it did seem like it took him longer to lose consciousness," Farrington says. "In Happ's case, his eyes were still opening two, three, four minutes into the process. Once they closed, about 10 minutes in, his head started moving kinda just around, and there was some motion."

There's no way to know if Happ was in pain during his last moments. Some anesthesia experts have expressed concern that midazolam and other untested sedatives could fail to work properly during an execution. If that happened, condemned prisoners could die slowly or painfully, a violation of legal guidelines for executions.

Megan McCracken studies lethal injection drugs for the Death Penalty Clinic at the University of California, Berkeley, School of Law.

"If the first drug does not in fact deeply anesthetize the prisoner," she says, "then he or she could be conscious and aware of being both paralyzed and able to experience pain and the experience of cardiac arrest."

In Search Of Drugs

NPR's Kathy Lohr has been covering the shortage of lethal injection drugs for years. She says the issue started when the drug company Hospira stopped making one of the most common drugs used in lethal injections, sodium thiopental. The anesthetic was used as part of a three-drug protocol.

"The company was the only maker of the drug in the United States," Lohr says. "But by 2011, the company stopped manufacturing it. In part, it really wanted to distance itself from executions."

The move caused a shortage, she says, "which basically led states to search for the drug wherever they could find it."

Some states began trading between themselves. Once the supply either runs out or expires, states are forced to come up with new protocols, find new drugs, or simply postpone the execution.

Missouri recently canceled an execution because it had planned to use propofol, a widely used anesthetic in U.S. hospitals. The drug is manufactured in Europe by the German company Fresenius Kabi. That potentially could have caused larger problems.

"The European Union has a statute that does not allow the export of any product that might be used in capital punishment," says company spokesman Matt Kuhn.

So when Fresenius Kabi got word of Missouri's plan to use the drug for capital punishment, it began limiting how the propofol would be distributed in the U.S. Kuhn says it supplies about 90 percent of the U.S. market for the drug.

"If propofol was used in an execution, then the likelihood of sanctions or a ban exporting it from the European Union would become a reality," he says. "And in turn, that would lead to a shortage of the product that's used 50 million times a year in the U.S."

Missouri announced Tuesday it would not use propofol; it's going to use pentobarbital instead.

Richard Dieter, who opposes the death penalty and directs the Death Penalty Information Center, says Missouri made the right decision in switching drugs.

"I think Missouri wisely got out of that whole crisis area and now finds a local pharmacy that will make a different drug, and joins Texas and some other states like Ohio and Georgia in this process," he says.

Compounding The Issue

But now there's another issue: Missouri and a number of states are now getting their drugs from compounding pharmacies. That bypasses the big European drug manufacturers altogether. The U.S. Food and Drug Administration doesn't regulate them, either.

"The drugs they're producing, including this pentobarbital, are not made specifically for executions and ... no court has actually reviewed this process," Lohr says. "So if the drugs cannot be validated as effective, this could be a violation of an inmate's Eighth Amendment right against cruel and unusual punishment."

Texas, Ohio and Missouri all have announced plans to use compounding pharmacies just this month.

"I think we should be using the best practice — not what's available," Dieter says. "And that's what we've come down to: What can the states get a hold of from the backroom of local pharmacies, rather than what's recommended by medical experts."

In addition, states are withholding details about the compounding pharmacies. Georgia inmate Warren Lee Hill is challenging the state's claim that the information should be kept secret.

"His attorneys say they need this information about where the drug is coming from and how it's manufactured — even to know if they can mount a legal challenge," Lohr says.

The states argue that the pharmacies may not want to sell the drugs if it's made public that they're contributing to capital punishment. A lack of sellers — and therefore drugs — could get in the way of carrying out executions.

"So that issue is now making its way through the courts in Georgia, and the execution of an inmate here, Warren Lee Hill, is on hold," Lohr says. "Also, more legal challenges are expected on this issue across the country."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.

Transcript

ARUN RATH, HOST:

It's ALL THINGS CONSIDERED from NPR West. I'm Arun Rath.

A little less than two weeks ago, the state of Florida executed convicted murderer William Happ using a combination of drugs never tried before.

(SOUNDBITE OF NEWS REPORT)

UNIDENTIFIED WOMAN: An execution scheduled to take place in Florida on Tuesday is facing controversy for using an untested lethal injection drug.

RATH: Florida is using an untested drug because of a nationwide shortage of approved lethal injection drugs. The death penalty may be settled law in America, but the way we implement it is very unsettled as states across the country sort out the proper way to execute inmates. That's our cover story today.

(SOUNDBITE OF MUSIC)

RATH: The story begins on May 25, 1986 and a note that our report includes details that some listeners will find disturbing. On that evening in May, a young travel agent named Angie Crowley was driving from Fort Lauderdale to Yankeetown, Florida. Late in the evening, the 21-year-old pulled up near a payphone to call her friend who was going to guide her the last few miles of the trip, but Crowley never made it to the phone.

At the rest stop, William Happ broke her car window, kidnapped and killed her. A fisherman eventually found her body in a nearby canal. In 1989, Happ was sentenced to death for Crowley's murder and rape. For decades, Happ appealed and lost. The sentence of death remained, but the method of execution changed. Since 1924, Florida had used the electric chair to execute prisoners, but in 2000, facing pressure from the Supreme Court, the state switched to lethal injection.

More than a quarter century after the murder of Angie Crowley, Happ's execution date was set. On October 15, 2013, he would die from a lethal injection of a three-drug cocktail. But the state had a problem: Supplies of the first drug in that cocktail, an anesthetic, were running low. As the execution date approached, the state ran out of the drug altogether. So the Florida Department of Corrections decided to use a new anesthetic, a sedative called midazolam that had never been tested for execution. Nobody knew exactly how it would work.

Brendan Farrington witnessed the execution of William Happ for the Associated Press. He described the scene in the viewing room.

BRENDAN FARRINGTON: The room has four rows of chairs, about 10 chairs in each row. The last row is slightly elevated, and that's where media witnesses are. It's a very solemn, serious, quiet atmosphere. There's no talking. They bring the witnesses in, and there's a screen across a long, rectangular window. And when they're ready to begin, the screen slowly rises. The person conducting the execution will announce that the sentence is about to be carried out, tell this to the condemned and asks if he has any last words.

In this case, William Happ gave a fairly lengthy final words. He admitted he committed the crime and expressed shame for it and said that, you know, he hopes that God forgives him, and he realizes that the family probably could not.

RATH: At 6 p.m. sharp, the execution began. Since the drug midazolam was being used for the first time in an execution, Farrington was watching closely to see how it would work.

FARRINGTON: While it wasn't dramatically different than previous executions, it did seem like it took him longer to lose consciousness. Of the other three executions I've seen, the condemned, once the procedure begins, they'll go under fairly quickly. And once their eyes closed, they usually stay closed. In Happ's case, his eyes were still opening two, three, four minutes into the process. Once they closed, about 10 minutes in, his head started moving kind of just around, and there was some motion.

RATH: There is no way to know if William Happ was in pain during his last moments. But some anesthesia experts have expressed concern that midazolam and other untested sedatives could fail to work properly during an execution. If that happened, condemned prisoners could die slowly or painfully, a violation of legal guidelines for executions.

Megan McCracken studies lethal injection drugs for the Death Penalty Clinic at the UC Berkeley School of Law. We reached her on her cellphone.

MEGAN MCCRACKEN: If the first drug does not, in fact, deeply anesthetize the prisoner, then he or she could be conscious and aware of being both paralyzed and able to experience the pain and then the experience of cardiac arrest.

RATH: NPR's Kathy Lohr has been covering the shortage of lethal injection drugs for years. I asked her how we got to this point with an acute shortage of lethal injection drugs and states considering untested alternatives.

KATHY LOHR, BYLINE: Well, it all started a few years ago when a drug company called Hospira stopped making one of the drugs that most states had used in their lethal injections, sodium thiopental. So the company was the only maker of the drug in the United States. It's an anesthetic, and it was used for years in lethal injections as part of this three-drug protocol. But by 2011, the company stopped manufacturing it. In part, it really wanted to distance itself from executions.

And when that happened, there was a shortage and which basically led states to search for the drug wherever they could find it. And so some were even trading it among each other if they had a larger supply and another state didn't have enough. But when that supply either expired or ran out, states had to come up with new protocols to conduct lethal injections. And basically, what that's meant is finding new drugs.

RATH: So what have the states been doing to find new drugs?

LOHR: Well, some states have been putting executions on hold - for example, California, North Carolina and Arkansas. But other states have been announcing the officials at the Department of Corrections have just announced that they're going to use these new drugs. So many are looking at pentobarbital. It's a sedative. And instead of doing three drugs, they'll just give a large dose of this single drug. Now, Missouri has an execution scheduled in November.

But Missouri's an interesting case because the governor there recently canceled an execution because the state had said it was going to use another drug, propofol. That is a widely used anesthetic in hospitals for a lot of surgeries.

So I spoke with Richard Dieter. He opposes the death penalty, and he's also the director of the Death Penalty Information Center. And he talks about what recently took place in Missouri.

RICHARD DIETER: Propofol, that's the most widely used anesthetic in the U.S. If it was restricted for distribution because of this rather small area of the death penalty, that would be a problem. So I think Missouri wisely got out of that whole crisis area and now finds a local pharmacy that will make a different drug and joins Texas and some other states like Ohio and Georgia in this process.

RATH: We talked to a spokesman for the company that supplies 95 percent of the propofol used in the U.S. Here is Matt Kuhn of the German company Fresenius Kabi.

MATT KUHN: When Missouri made its announcement last year that it was considering propofol as a single-agent protocol for its executions, we implemented distribution controls. We limited the number of distributors who could distribute the product in the U.S. And we reached agreement with those distributors that they would not sell the product to departments of corrections in the U.S.

RATH: Kuhn explained why the company had to take steps to prevent state departments of corrections from using propofol in executions.

KUHN: The propofol from Fresenius Kabi is manufactured in Europe. And the European Union has a statute that does not allow the export of any product that might be used in capital punishment. And so the fact that we supply 90 percent of the U.S. market, if propofol was used in an execution, then the likelihood of sanctions or a ban exporting it from the European Union would become a reality. And in turn, that would lead to a shortage of the product that's used 50 million times a year in the U.S.

RATH: So, Kathy, just this week, Missouri announced that it would not use propofol. They're going to start using pentobarbital. But another new issue is that Missouri and a number of states now say that they're getting their drugs from compounding pharmacies. That bypasses the big European drug manufacturers altogether. But there are some concerns about that approach, too, right?

LOHR: Yes. Those who are challenging this idea say that the pharmacies may not be reliable. The issue is that these compounding pharmacies are not regulated by the FDA. So that's been called into question. And Texas, Ohio and Missouri all have announced plans to use compounding pharmacies just this month. The drugs they're producing, including this pentobarbital, are not made specifically for executions. And nobody has - basically no court has actually reviewed this process.

So if the drugs cannot be validated as effective, this could be a violation of an inmate's 8th Amendment right against cruel and unusual punishment. So here again is Richard Dieter, and he explains what the problems could be if these drugs are not effective, if they're contaminated or if they just don't work as intended.

DIETER: It could be painful. It could be, you know, partial unconsciousness and a person, you know, slowly going through conscious knowledge of their dying and their pain but not being able to shout out or move. There's a lot of things. I think we should be using the best practice, not what's available. And that's what we've come down to. You know, what can states get a hold of from the backroom of local pharmacies rather than what's recommended by medical experts.

RATH: Kathy, I understand states are also refusing to release any details about these compounding pharmacies. They're keeping the details a secret?

LOHR: That's right. In Missouri, the officials just announced that keeping the pharmacy details a secret is going to be written into the law. And Georgia recently passed a law that says the identity of people or companies that manufacture or supply these drugs used in executions is a classified and confidential state secret.

Now that's, you know, caused some uproar here, and a Georgia inmate is challenging the law in court. His attorneys say they need this information about where the drug is coming from and how it's manufactured, even to know if they can mount a legal challenge.

RATH: So why is the state keeping this a secret?

LOHR: Well, the state has argued there's a good reason to protect the identity of these pharmacies because they say that if they revealed the information, the pharmacies may not want to sell drugs to the state, and that would prevent them from carrying out executions. So that issue is now making its way through the courts in Georgia. And the execution of an inmate, Warren Lee Hill, it's on hold. Also, more legal challenges are expected on this issue across the country.

RATH: NPR's Kathy Lohr joined us from Atlanta. Kathy, thank you.

LOHR: My pleasure.

RATH: On November 12th, Florida will use midazolam for the second time. On the same day, Texas will carry out an execution with pentobarbital. It will likely get from a compounding pharmacy. And across the nation, the legal challenges continue as states struggle with a shortage of the only drugs approved for execution.

(SOUNDBITE OF MUSIC)

RATH: This is NPR News. Transcript provided by NPR, Copyright NPR.

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