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Secrecy around Missouri execution drug is drawing criticism

Updated: 2013-11-09T05:05:29Z

By TONY RIZZO

The Kansas City Star

It’s no secret that Missouri’s new execution drug is an effective killer.

Veterinarians use it to euthanize cats and dogs every day, and it has been employed as the sole drug in 30 U.S. executions this year.

What is secret is the name of the compounding pharmacy that will supply pentobarbital as Missouri’s lethal injection agent.

And that secrecy, along with a growing concern about the unregulated nature of such pharmacies, could propel the state into a protracted legal fight before it can carry out its first execution since early 2011.

A similar situation in Georgia this summer prompted a stay of execution after a judge found that putting an inmate to death with secretly compounded pentobarbital raised crucial constitutional questions.

“There are a lot of serious problems with all of this,” said Deborah Denno, a law professor at Fordham University in New York who has done extensive research on issues surrounding lethal injection across the country.

In an article for the Georgetown Law Journal, Denno said that the “historically dismal safety standards and haphazard daily practices” of some compounding pharmacies “all but invite lethal injection challenges.”

Compounding is the traditional pharmacy practice of mixing medications from scratch to meet the needs of individual patients. Critics say some pharmacies have grown to resemble large-scale drug manufacturers that do not have to comply with the same level of regulation as conventional drug makers.

Missouri is among a growing number of death penalty states turning to compounding pharmacies to supply execution drugs because large drug manufacturers, many based in Europe, have balked at allowing their products to be used to execute prisoners.

And compounding pharmacies, which are not regulated by the U.S. Food and Drug Administration, are facing increased scrutiny over the safety and effectiveness of their products. The most disturbing and high-profile case arose in Massachusetts last year, after dozens of people died from a fungal meningitis outbreak linked to a compounding pharmacy.

“Compounding pharmacies are already under such scrutiny as it is, they don’t need any more negative attention,” Denno said. “And there is nothing more negative than being associated with executions in this country.”

Oversight of compounding pharmacies is primarily left to the states. Missouri’s extensive regulations include quality-control standards and testing of products.

But concerns about compounding pharmacies have led to proposed legislation in Congress to more tightly regulate them at the federal level.

Those concerns also have opened the door to challenges from lawyers representing death row inmates who contend that improperly prepared or impure drugs could lead to painful deaths and thus violate constitutional protections against cruel and unusual punishment.

“There are a lot of questions a judge is going to want answered before using it on a human being,” said Richard Dieter, executive director of the Death Penalty Information Center.

Because states like Missouri keep the identity of their execution teams confidential and have now included the pharmacy on its team, attorneys for inmates say they have no way of knowing if the drugs obtained from such sources will work as intended.

Denno said the states traditionally have kept the names of individual executioners secret to shield them from harassment or retaliation, but affording that same anonymity to a company may be an effort to shield it from the kind of publicity that led large drug manufacturers to balk at supplying execution drugs.

In response to a request for comment about compounding pharmacies and whether the state intends to use one from Missouri or another state, the corrections department reiterated in writing that “any portion of a record containing identifying information related to a member of the execution team is privileged and not subject to discovery, subpoena, or other means of legal compulsion, or subject to disclosure.”

The American Civil Liberties Union recently filed suit against the Missouri Department of Corrections over making the source of its drugs part of the confidential execution team.

Missouri’s first execution using its new protocol employing pentobarbital is scheduled for Nov. 20. Lawyers for that inmate, Joseph Paul Franklin, have already raised questions about the new protocol in legal filings.

“Time does not permit Mr. Franklin to develop a full-fledged body of scientific evidence to attack the use of drugs that have not been identified or examined, and whose manufacture and provenance are unknown,” they contended in a motion seeking to vacate Franklin’s execution date.

The Missouri Supreme Court overruled that motion without comment, but attorneys representing 21 Missouri death row inmates, including Franklin, in a separate federal lawsuit, have said that litigation over Missouri’s new lethal injection protocol is a “virtual certainty.”

That federal suit involved the drug Missouri previously had intended to use to execute condemned prisoners. But the state scrapped plans to use propofol after its European-based manufacturer warned that it would limit imports of the drug to the United States, which could trigger a nationwide shortage of the widely used surgical anesthetic.

Attorneys for the state have moved to dismiss that suit as moot because the state no longer intends to use propofol. But attorneys for the inmates are asking for more time to respond and to determine if they will amend the suit to raise the pentobarbitol issue or file a separate suit.

In their legal filings, attorneys for the state note that the use of pentobarbital has been found constitutional in multiple court rulings.

Mark Dershwitz, an anesthesiologist at the University of Massachusetts Memorial Medical Center who has testified as an expert in many death penalty- related cases, provided a report to the state in which he said that pentobarbital, “as used in the Missouri lethal injection protocol, will result in the rapid and painless death of the inmate to whom it is administered.”

But death penalty experts say that presumes the drug being used is properly manufactured and administered.

“Maybe it works if it’s pure,” Dieter said. “But once we get into compounding pharmacies, are we sure it is what it claims to be?”

The judge in Georgia who halted the execution of Warren Lee Hill this summer raised the same kind of questions over that state’s source of drugs and the secrecy surrounding it.

“Without more information, the court finds that plaintiff still, today, cannot possibly determine whether or not the pentobarbital in question was somehow contaminated or otherwise improperly compounded,” the judge wrote.

Larry Sasich, a drug safety consultant hired by Hill’s defense team reported that the growth of compounding pharmacies “represents an emerging, substandard drug industry responsible for making large quantities of unregulated, unpredictable and potentially unsafe drugs.”

“The compounded drug may be contaminated, super- or sub-potent, making it unpredictable and potentially dangerous in that it may pose a high risk of pain and suffering to the ‘patient’ to whom it was administered,” Sasich said in his report to the Georgia court.

The Georgia Supreme Court is now considering the case.

The International Academy of Compounding Pharmacists has not taken a formal position on compounding pharmacies’ preparation of drugs used in executions.

“The pharmacy profession recognizes an individual practitioner’s right to refuse to dispense a medication based upon his or her personal, ethical and religious beliefs,” the academy said in a written statement. “In a very small number of cases, compounding pharmacies have been asked by their state government to assist in preparing drugs used in executions because pharmaceutical manufacturers have unilaterally restricted distribution.”

Robert Blecker, a professor at New York Law School and death penalty proponent, says he has no doubt that anti-death penalty advocates will challenge the legality of execution methods like that in Missouri.

But he said such challenges will pass and they are not relevant to the real question when it comes to capital punishment.

“Who, if anyone, deserves to die?” he asked. “Are we using it for the worst of the worst, and are safeguards in place to ensure we don’t execute an innocent person?”

To reach Tony Rizzo, call 816-234-4435 or send email to trizzo@kcstar.com.

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