PharmaView: Sell No Harm

Makers of drugs for lethal injection face pressure to spurn U.S. prisons.

By Paul Thomas, Senior Editor

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“First, do no harm.” It’s a tenet that physicians swear by, and most drug manufacturers have adopted a modified version as part of their credos: to make products that “save and improve lives,” as Merck’s mission says for instance.

But drugs that save and improve lives can often take lives as well. When this happens, manufacturers have an ethical responsibility—to patients and shareholders—to investigate and intervene. (See, for example, “What’s the Prescription for Painkiller Nation?”)

Last year, Hospira—whose motto is “Advancing Wellness”—stopped making its anesthetic Pentothal, or sodium thiopental. There was a patient need and market for the drug, but one segment of that market was too controversial and deemed a business risk. For years, sodium thiopental had been used by U.S. prisons for their death row executions.

The U.S. is one of fewer and fewer nations where capital punishment is still legal. States choose for themselves, and 34 of the 50 have decided in favor of the death penalty. In the effort to find a “humane” means of killing, they have adopted lethal injection—typically a cocktail of three drugs: one to render the person unconscious, a second to cause paralysis, and a third to stop the heart. Sodium thiopental has been administered for the first stage, though more recently some states had begun to deliver a single, massive dose of the drug by itself to bring on death.

Hospira had intended to resume production of the drug in Italy, but faced intense international pressure, and legal threats from the Italians themselves. Given the vagaries of today’s pharmaceutical supply chain, the company could offer no assurance whose hands (and veins) Pentothal would end up in.

“We cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment,” the company stated. “Exposing our employees or facilities to liability is not a risk we are prepared to take. . . . We regret that issues outside of our control forced Hospira's decision to exit the market, and that our many hospital customers who use the drug for its well-established medical benefits will not be able to obtain the product from Hospira.”

A sodium thiopental shortage ensued. For a time, the U.K.’s Dream Pharma picked up the slack, before the British government banned it from exporting. Several U.S. states were forced by the U.S. Drug Enforcement Agency to hand over product obtained from Dream. It got to the point that prisons with inmates on death row were turning to the gray market, or soliciting sodium thiopental from correctional facilities in other states.

Many sought an alternative drug and turned to the epilepsy medication pentobarbital, manufactured by Denmark’s Lundbeck under the name Nembutal.

It has since been Lundbeck’s turn to face intense scrutiny. Initially the company said the right things, that using pentobarbital for executions is a "distressing misuse" of its product. (It’s mission statement: “To improve the quality of life for people suffering from psychiatric and neurological disorders.”) "The use of pentobarbital to end people's lives contradicts everything that we're in business to do," the company stated earlier this year. Yet it pleaded that it was powerless to do anything about the matter.

Pressure mounted. “We are appalled at the inaction of Lundbeck to prevent the supply of their drug,” physicians groups wrote last June in The Lancet. In response, Lundbeck has done an about-face and has begun a proactive program to monitor all of its orders and require customers to guarantee—through “end-user agreements”—that the drug will not be used for executions.

Says Managing Director Ulf Wiinberg: "While the company has never sold the product directly to prisons and therefore can't make guarantees, we are confident that our new distribution program will play a substantial role in restricting prisons' access to Nembutal for misuse as part of lethal injection."

To be fair to Lundbeck, that’s about all it can do. And it is probably enough to force prisons in the U.S. to find another alternative for their lethal injections. (Some have suggested it might be propofol, though this drug, incidentally, is also experiencing a supply shortage as Teva has exited the market and Hospira has faced manufacturing issues.)

Pro or con, we all have intense, deep-seated feelings about the death penalty. But for drug companies the choice should be simple—first, do no harm. They must do everything in their powers to prevent their products from being used to kill.

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