The sole U.S. maker of a key execution drug has decided to permanently halt production of the drug, which could lead many states to face delay in carrying out the death penalty.
The decision made on Friday by Hospira Inc. caps months of controversy over thiopental sodium, an anesthetic that has long been used by states as a part of a cocktail of drugs administered during a lethal injection.
Hospira's decision puts a wrench in the nation's capital-punishment system. States can attempt to use another anesthetic in place of thiopental, but such a switch likely would need to be approved by courts and possibly state legislators.
Many states have run out of thiopental, forcing prison officials to delay executions. The drug shortage followed a 2009 decision by Hospira to suspend production due to manufacturing issues.
The Lake Forrest, Ill., company had planned to resume producing thiopental in the first quarter of 2011 at a company plant in Liscate, Italy. But in December, the Italian parliament issued an order binding the government to ensure that Hospira's Italian-made thiopental would not be used in lethal injections.
In the face of that opposition, Hospira ultimately decided to exit the thiopental market, said company spokeswoman Tareta Adams. "This will be a challenge for [medical] customers and we regret that," Ms. Adams said. "But we don't want to put our Italian facility at risk that the product will be misused" by U.S. prisons.
Hospira, she said, has had discussions with its drug distributors to see if the companies could block the drug from being sold to prisons, but Hospira ultimately decided there was no way to ensure the drug would not be "misused" by prisons.
Late last year, a drug used to euthanize animals was approved for use in capital punishment in Oklahoma. The shortage of thiopental sodium had prompted the state to seek court clearance to use pentobarbital as a substitute.
U.S. District Judge Stephen Friot in November approved the use of pentobarbital and denied requests to delay the executions of two Oklahoma inmates, whose attorneys had protested its use.
The state has said in court filings that veterinarians regard pentobarbital "as an ideal anesthetic agent for humane euthanasia in animals" and that it is "substantially" similar to thiopental.
Judge Friot's ruling could prompt other states to use pentobarbital, and thus prevent delays in capital punishment. In the early 1970s, Oklahoma was the first state to approve the use of thiopental in capital punishment, and it later become the nationwide standard for lethal injections.
Source: The Wall Street Journal, January 21, 2011
How Italian Catholics pulled the plug on US executions
Hospira Inc. of Lake Forest, Ill, had decided to switch production of the anaesthetic sodium thiopental from its North Carolina plant to Liscate, outside of Milan. But the Italian Parliament wanted the company to control the product's distribution to prevent it being used for executions. Hospira decided it couldn't make that promise and has decided to suspend production -- potentially throwing the death penalty system in the US into disarray.
But what's missing from today's reports is that behind the Italian Parliament's insistence is a lay Catholic movement dedicated -- among many other things - to the eradication of the death penalty around the world. The Rome-based Community of Sant'Egidio had been engaged in discussions with Hospira's Italian subsidiary, Hospira SL, which led to meetings with the Foreign Affairs minister, Franco Frattini, and the Ministry of Health. The result of those meetings was an agreement that the production of the drug in Italy would have to be for strictly therapeutic purposes. The company has long deplored its use in executions, and said it regretted the need to cease production.
Hospira's choice to end production because it couldn't give that guarantee was described as "highly responsible" by Sant'Egidio's spokesman, Mario Marazziti, who said: "It highlights the point that therapeutic drugs and doctors should never be used to bring about death".
Sodium thiopental is already in short supply after the British government last November also banned the UK manufacture of the drug following a campaign by the British NGO Reprieve. According to the Wall Street Journal's law blog, Hospira's decision means the death penalty system in the US "is potentially thrown into turmoil". States can attempt to use another anaesthetic instead -- Oklahoma, for example, has switched to a drug used to euthanise cats and dogs -- but it involves seeking clearance from the courts, which is likely to delay executions.
There is a lesson here about globalization. It's not just the market that's gone global. It's civil society pressure, too.
Source: America Magazine, January 21, 2011
States Face Shortage of Key Lethal Injection Drug
The sole American manufacturer of an anesthetic widely used in lethal injections said Friday that it would no longer produce the drug, a move likely to delay more executions and force states to adopt new drug combinations.
The manufacturer, Hospira Inc., of Lake Forest, Ill., had originally planned to resume production of the drug, sodium thiopental, this winter at a plant in Italy, giving state corrections departments hope that the scarcity that began last fall would ease.
But the Italian authorities said they would not permit export of the drug if it might be used for capital punishment. Hospira said in a statement Friday that its aim was to serve medical customers, but that “we could not prevent the drug from being diverted to departments of corrections” and the company did not want to expose itself to liability in Italy.
Hospira does not have domestic facilities that can make sodium thiopental, said Daniel Rosenberg, a spokesman, and has decided to “exit the market.” No other American companies manufacture the drug, which has largely been supplanted by alternatives in hospitals but is used by 34 of the 35 states that use lethal injection to carry out the death penalty. An average of 55 executions have taken place annually over the last 10 years, with 46 last year and 52 in 2009, virtually all of them by lethal injection.
During what had been described as a temporary halt to production last year, scarcity of sodium thiopental led to delays in scheduled executions in at least two states, California and Oklahoma.
The extent to which execution schedules will be further disrupted by the drug shortage is not yet clear, but it could be considerable. In many states, adopting a new protocol for lethal injections requires formal proposals, public comment and often challenges in court — a process that can take months or more, said Richard Dieter, executive director of the Death Penalty Information Center. But in others, switching drugs might be done more quickly, by administrative fiat.
Lethal injections commonly involve a sequence of three drugs that is set by state regulations: an anesthetic — sodium thiopental in every state but Oklahoma — intended to prevent pain, followed by a muscle relaxant and a drug that stops the heart.
As the shortage became acute last fall, California and Arizona obtained shipments of sodium thiopental from England, but the British government has since refused to allow exports of drugs for use in capital punishment, a policy that is under consideration by the entire European Union.
Those were two of several special shipments to corrections departments permitted by the Food and Drug Administration in 2009 and 2010, said Christopher Kelly, a spokesman for the agency. “No shipments are currently being held,” Mr. Kelly said on Friday.
Texas, which carries out more executions than any other state, has an aging stock of sodium thiopental that will expire in March, leaving it unusable.
“There currently are four executions scheduled in Texas — two in February, one in May and one in July,” said Michelle Lyons, director of public information at the Texas Department of Criminal Justice. “At this time, we have enough sodium thiopental on hand to carry out the two executions scheduled in February. In March, our supply of this particular drug is set to expire.”
“The Texas Department of Criminal Justice will explore other options, including possibly seeking an alternate drug for use in Texas’ lethal injection process,” she said in an e-mail.
Two states, Ohio and Washington, use only one drug, sodium thiopental, which is fatal at larger doses for executions.
“What I can tell you is Ohio does have enough sodium pentothal to carry out the execution scheduled in February,” said JoEllen Smith, a spokeswoman for the Ohio Department of Rehabilitation and Correction, using an alternate name for the drug. “But beyond that we are going to decline to comment on our supply of the lethal injection drug.”
Officials in Washington said that they had not had time to consider how to adapt to the news that sodium thiopental will no longer be available. The state has seven people on death row, but no executions are currently scheduled.
Officials in Arizona, where 134 people are on death row, said they had enough sodium thiopental for five executions, although none are currently scheduled.
Many states are expected to follow the lead of Oklahoma, substituting pentobarbital — another, more easily available anesthetic — in a similar three-drug sequence.
Pentobarbital is widely used in veterinary medicine and is also used in legal human euthanasia in Oregon. Death penalty opponents challenged the switch last year in Oklahoma, arguing that the effectiveness of pentobarbital in preventing pain during executions had not been proved. But a federal judge sided with the state, which has since used the new drug in three executions.
Jerry Massie, a spokesman for the Oklahoma Department of Corrections, said the department orders the drug through a “private pharmacist” but would not specify who.
Only one company, Lundbeck Inc., now markets injectable pentobarbital in the United States, according to the F.D.A., but the agency said it was not aware of any shortage.
Source: The New York Times, January 22, 2011
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