The Executioner’s Drug
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 spokesperson Dan 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.”
Hospira’s decision worsens the shortage of the drug, and foreign supplies are dwindling. Countries such as Germany and the United Kingdom are refusing to export it to the US.
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.
Erik,
It appears as though you either misunderstand the regulation of drugs or maybe just some of the wording here makes me think that is the case.
The FDA does not have authority to limit the practice of medicine. In many (most?) states where capital punishment is practiced, the state has a physician on staff who is actually setting things up and who has determined the proper drugs for use in the injection sequence. Assuming this is the case, then the FDA has no oversight responsibility at all. In fact, FDA has, since its establishment in the 1930s, stated that it is not mandated to interfere in the practice of medicine. For most indications, there are no drugs “approved” for use. For example, almost none of the drugs prescribed to children have ever been “approved” for use in children by FDA based on clinical studies (except for the relatively new rules allowing for an addition 6 months of exclusivity for pediatric indications).
As such, nothing is really out of the ordinary in this situation.
Hi, Vic. Thanks for your comment. Yes, you’re right that FDA does not regulate the practice of medicine. I did not mean to imply that it did, but I can see how my post could be interpreted that way.
Since you mention the practice of medicine, though, I’ll note that I find it ironic that physicians would choose drugs to be used for lethal injections and even administer these injections. Doctors, after all, have sworn to do no harm and not to play God in matters of life and death.
I don’t think it’s correct to say that drugs are not approved for specific indications, however. If they were not, pharmaceutical companies would not stir up controversy or incur fines when they encouraged doctors to prescribe drugs for off-label uses. You’re right, though, that drugs currently are not approved for specific populations such as children.
Erik