FDA’s Immoral Stance on Lethal Injection Drugs

By Raymond Bonner 2012-07-29T22:30:04Z

The mission of the Food and Drug Administration is to protect us from drugs that might kill because they are impure, badly manufactured, untested. Well, not all drugs, as it turns out.

When it comes to drugs used in executions, the FDA says it doesnt check on their potency, safety or effectiveness. Thus, the agency allowed a small company in Mumbai that stored its drugs in a room without air conditioning to sell Nebraska enough sodium thiopental for 166 executions.

It permitted a tiny wholesaler, Dream Pharma, operating out of two rooms in the back of a driving school in London, to sell sodium thiopental -- the most critical drug in executions -- to Georgia, Arkansas, Tennessee, South Carolina and California. The FDA even helped expedite a shipment of sodium thiopental to Arizona because it was for the purpose of executions and not for use by the general public, the deputy director of the Arizona Department of Corrections wrote in an e-mail to his counterpart in California.

This caused one death penalty lawyer, Clive Stafford Smith, to say sarcastically that drugs can be expedited if they are meant to kill someone, but apparently not if they are meant to save lives.

The conundrum for the FDA, which has now been sued, arose when the only U.S. company that had FDA approval for sodium thiopental, Hospira (HSP), ceased production. With that, death penalty states scrambled abroad for the drug, an anesthetic, and their problems escalated.

Lethal injection was first proposed in the 19th century by a New York doctor who argued it would be cheaper than hanging. Oklahoma was the first state to deploy it, in 1977, and eventually all death penalty states followed. Most have used a three-drug protocol administered through IVs inserted into the arms of the prisoner, who is strapped onto a gurney. The first is the anesthetic. This is to render the prisoner unconscious so that he does not suffer the pain when the next drugs are injected.

The second drug, pancuronium bromide, paralyzes the diaphragm and lungs, making it impossible for the condemned to breathe. Finally potassium chloride is injected, causing death by cardiac arrest.

In a landmark ruling in 2008, Baze v. Rees, the Supreme Court held that lethal injection was not cruel and unusual punishment, which is proscribed by the Eighth Amendment.

But the court didnt give blanket approval to this method of execution. The majority looked specifically and carefully at the three-drug protocol used in Kentucky that was spelled out in detailed regulations. These ranged from the amounts of drugs to the requirement that only qualified personnel could insert the IVs in the prisoners arms. The court concluded that this protocol did not present a substantial risk of serious harm, or an objectively intolerable risk of harm, which is the test for whether a punishment violates the Eighth Amendment.

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FDA’s Immoral Stance on Lethal Injection Drugs