Execution drugs mixed by US pharmacies draw death row challenges

Execution drugs mixed by US pharmacies draw death row challenges

Oct. 13, 2013 at 10:55 AM ET

KANSAS CITY, Mo. — 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.”

LIFTING SECRECY 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.

Copyright 2013 Thomson Reuters.

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