The Executioner and the FDA

For want of a nail the shoe was lost,

For want of a shoe the horse was lost;

[For want of a drug a life was prolonged-briefly]
--A Proverb

It is easy to lose sight of one's mission and we should be
sympathetic and not critical. After all, its employees are busy people
and that probably helps explain why the Food and Drug Administration has
momentarily gotten confused as to its purpose. On its website it says
the FDA" "is an agency within the Department of Health and Human
Services . . . [that] is responsible for protecting the public health by
assuring the safety, efficacy, and security of human and veterinary
drugs. . . . " It is "also responsible for advancing the public health
by helping to speed innovations that make medicines and foods more
effective, safer, and more affordable; and helping the public get the
accurate, science-based information they need to use medicines and
foods, and to reduce tobacco use to improve health."

An example of its good work was the announcement last November that
it was going to make cigarette companies put really awful pictures of
people adversely affected by tobacco on each pack of cigarettes to
discourage those offended by such gruesome pictures from smoking.
Health and Human Services Secretary Kathleen Sebelius said
at a news conference: "We want to make sure every person who picks up a
pack of cigarettes knows exactly what the risk is they are taking. "

In January the FDA announced
new restrictions on some of the most popular prescription painkillers
because they caused "many patients to poison themselves with overdoses
of the drug acetaminophen." This was yet another example of the FDA
looking out for the best interests of the public that it is charged with
safeguarding. Helping the general public enjoy better health is not
all it has been doing, however. It has also been helping penitentiaries
in California and Arizona execute their death row inmates by providing
sodium thiopental.

Executioners in the United States are suffering from a short supply
of sodium thiopental. Hospira Inc. of Lake Forest, Illinois is the only
American manufacturer of the product and it says that it has
encountered supplier issues that have made it impossible to manufacture
the drug. As was observed in this space a few weeks ago, although
Texas has enough of the drug on hand to dispatch more people on death
row than it can possibly use before the expiration date of the drug, it
does not want to share with other states for reasons best known to
itself. As a result of Texas's unwillingness to share, Arizona found
itself in the position of having the execution of Jeffrey Landrigan
delayed due to the unavailability of domestically produced sodium
thiopental. Although the drug was available from a British firm, Mr.
Landrigan's attorneys feared it might not measure up to the high quality
executioners in this country had come to expect from the domestically
produced drug.

Arizona was not the only state that found itself in the awkward
position of having people ready to be executed but no available drugs to
get the job done. California was in a similar spot. San Quentin was
suffering from a lack of the drug and feared that its executions might
also have to be postponed until the drug became domestically available
once again. And here's where the FDA came to the rescue. In a report in
the Washington Post
on January 11, 2011 by Andrew Welsh-Huggins, it was disclosed that
Arizona had written the FDA explaining the dreadful dilemma it
confronted and asking for the FDA's help. When the FDA learned of the
dilemma facing Arizona and California, one of its officials stepped up
to the plate and recommended that a shipment of the drug "be processed
expeditiously to us as it was for the purpose of executions and not for
use by the general public." (Why it needed to be processed
expeditiously when the general public was not the beneficiary of the
effort is hard to understand. Perhaps the official making the
recommendation is a supporter of the death penalty and hated see the
execution process delayed for lack of a drug that was readily available
in England.)

It seems a bit odd to have the FDA expediting executions. As
Natasha Minkser, the death penalty policy director for the ACLU's
Northern California chapter said: "The FDA is actively assisting these
states, but they're not enforcing the law, and they're not doing
anything to determine that the drugs are what they're claimed to be and
that they work properly." It is unlikely that Ms. Minkser would feel
better if the FDA tested the drug to make sure it works "properly"
before forwarding it to the states. Indeed, it is not clear that the FDA
should care a fig for whether the drug works properly. It should not
be in the death dealing business. Someone should tell Ms. Sebelius.