At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing.
To avoid liability, Hospira decided to stop manufacturing sodium thiopental, an anesthetic used to administer lethal injections. The company planned to manufacture the drug at its site in Italy until that country’s authorities chose to forbid its export, fearing that it would be used for capital punishment. Hospira was the lone US manufacturer of sodium thiopental.
“Hospira manufactures this product because it improves or saves lives, and the company markets it solely for use as indicated on the product labeling,” said company spokespersonDan Rosenberg in September 2010, referring to sodium thiopental. “The drug is not indicated for capital punishment, and Hospira does not support its use in this procedure.”
Oklahoma uses pentobarbital, another anesthetic, in place of sodium thiopental. The state administers the anesthetic as part of the traditional three-drug lethal injection procedure. But critics say that pentobarbital’s effectiveness in preventing pain is unproven.
Ohio plans to administer pentobarbital alone to execute inmates, and defense attorney David Stebbins is concerned about this plan. “We just don’t have any information on that, and I’m not sure anybody does since it’s never been used that way,” he told the Associated Press.
So here we have a state administering a substitute drug in a use for which it is not indicated, seemingly without FDA oversight. If the agency’s mandate is to ensure the safety, efficacy, and security of human drugs, should it be regulating the drugs used for lethal injections? On the other hand, why should we be concerned with the health, safety, or comfort of someone whom we have deemed unworthy of life?
The search for new suppliers of, and alternatives to, sodium thiopental emphasizes the inherent contradictions of capital punishment. The events also reveal an oddity in the way that we regulate drugs.