By Carey Gillam
KANSAS CITY, Missouri (Reuters) - Several U.S. states are turning to lightly regulated pharmacies for lethal injection drugs, prompting a host of court battles and at least one stay of execution because of concern tainted or impure drugs could inflict cruel and unusual punishment on inmates.
The scramble for alternative supplies comes as major pharmaceutical companies, especially based in Europe, have clamped down on sales of drugs for executions in recent years in order to avoid association with the punishment.
Missouri on Friday abandoned a plan to use the anesthetic propofol to put an inmate to death after the German maker of the drug, Fresenius Kabi, discovered that some had been sold to the state for executions, and suspended shipments to a U.S. distributor in retaliation.
Cut off from traditional sources of drugs, at least five states where the death penalty is legal - South Dakota, Texas, Ohio, Georgia and Colorado - are looking to "compounding" pharmacies, which typically mix drugs for prescriptions and are mostly exempt from federal oversight and face widely varying scrutiny from states.
Tainted drugs from a Massachusetts compounding pharmacy caused an outbreak last year of a rare type of meningitis that killed more than 50 people and sickened more than 700 in 20 states, according to the U.S. Centers for Disease Control and Prevention. The resulting outcry has sparked a drive in Congress for a larger role by the U.S. Food and Drug Administration, which has warned of "special risks" from compounding pharmacies.
No judge appears to have ruled that an execution was botched from compounded drugs. But death penalty opponents have filed a flurry of lawsuits seeking to halt executions using them.
They say the use of compounded drugs runs the risk of violating the 14th Amendment to the U.S. Constitution, which forbids states from inflicting "cruel and unusual punishment."
"You don't have a high level of assurance that the drug is pure and potent," said Sarah Sellers, a pharmaceutical consultant who testified twice about the risks of compounders before the Massachusetts Legislature after the meningitis outbreak. "When used in executions, they are a real concern. It could take longer to die, there could be unnecessary suffering."
Compounders and prison officials reject that view, saying the industry does good work, and that executions happen too fast for tainted drugs to mar the process.
A spokesman for the compounding industry, David Ball, said he was aware of only three pharmacies that had supplied compounded drugs for lethal injections, and that the industry in general was of "high quality."
"No compounding pharmacy that I know of is actively seeking this business," he said. "Every pharmacist that I know chose their profession in part out of a desire to help people, and that is what they focus on in their work."
The results of the court challenges have so far been mixed. In their biggest success, a Georgia judge in July granted a stay of execution for death row inmate Warren Lee Hill. Among the reasons Fulton County Superior Court Judge Gail Tusan cited were questions whether Georgia's lethal injection drug was "somehow contaminated or improperly compounded." The state Supreme Court is considering the case.
Other judges have allowed executions to go ahead. In a case brought by three Texas death row inmates, among them Michael Yowell, challenging the use of the drug pentobarbital from a compounder, a judge said he was not persuaded.
"Pentobarbital will kill Yowell in five to eighteen minutes and his consciousness will be diminished almost immediately; therefore, infections like meningitis will not hurt him because they require weeks to incubate," wrote U.S. District Judge Lynn Hughes.
Yowell was executed on Wednesday, the first Texas inmate put to death using the compounded drug.
Compounding pharmacies combine or alter drugs mostly to fill individual prescriptions for patients.
The FDA, which regulates drug manufacturers, does not approve the products of compounding pharmacies, which are licensed through state pharmacy boards.
An FDA study found the potency of compounded drugs can vary widely from that listed on the label, and the agency has cited numerous cases of contamination from such operations.
The U.S. House of Representatives passed a bill on September 28 to give the FDA more authority over compounding pharmacies, although the measure is unlikely to become law soon because of the political gridlock in Washington over the budget, national debt and health reform.
In response to concerns about the quality of drugs, Texas had an independent laboratory, Eagle Analytical Services, test the state's compounded pentobarbital used in executions and it was 98.8 percent pure, court documents in the death row inmates case showed.
"Thousands of individuals use compounded drugs each day," said Jason Clark, spokesman for the Texas Department of Criminal Justice. "The quality and potency of the compounded pentobarbital will not differ from the pentobarbital that is manufactured by a pharmaceutical company."
The scramble for new sources of execution drugs has been accompanied by an effort to shield the process from scrutiny, which advocates for death row prisoners find troubling.
"The lack of transparency around the form and source of the drugs puts our clients at an unjustified risk of being executed with drugs that either will not work as planned or will cause excruciating pain and suffering," said Bryan Stull, a lawyer specializing in capital punishment for the American Civil Liberties Union.
Court challenges and media scrutiny have been more successful in prying information about the compounded drugs from state authorities than in delaying executions.
South Dakota had refused to identify where it got the drugs that it used to execute an inmate last year. A judge on September 30 ordered the state to turn over some information to him, although he said the identity of the compounding pharmacist need not be disclosed publicly.
Earlier this year, Colorado officials turned to compounding pharmacies to seek out sodium thiopental, a common execution drug until major drug companies two years ago refused to supply it. The information was disclosed in a letter sent by the Colorado corrections department to compounding pharmacies that became public in a lawsuit filed in May by the ACLU.
Ohio, which is running out of usable drugs for executions, announced on October 4 that it would allow the purchase of drugs from compounding pharmacies if needed.
Texas, which executes more inmates than any other state, stirred debate over whether it had promised secrecy to a supplier, when it identified the compounder earlier this month.
On October 2, in response to a media public information request, the state criminal justice department said it had purchased pentobarbital for executions from Houston-based Woodlands Compounding Pharmacy.
Two days later, the owner of the pharmacy sent a letter to Texas corrections officials saying he wanted the drugs back because the company had been subjected to public criticism.
"It was my belief that this information would be kept on the 'down low' and that it was unlikely that it would be discovered that my pharmacy provided these drugs," owner Jasper Lovoi said in the letter, which was disclosed in documents as part of a federal lawsuit filed against the state by three death row inmates.
The Texas Department of Criminal Justice said it had purchased the drug legally and had no intention of returning it.
(Additional reporting by Jim Forsyth in San Antonio and Karen Brooks in Austin, Texas; Editing by Greg McCune, Peter Henderson and Peter Cooney)