Beaty v. FDA Appealed

No surprise, the FDA has appealed US District Court Judge Richard Leon's ruling on Beaty et al. v. Food and Drug Administration et al., No. 11-cv-289. Nebraska refused to obey the order and urged the FDA to appeal. See Nebraska's Thiopental for Lethal Injection for some links and details.

Oklahoma's Attorney General was joined by the Nebraska AG and thirteen others in a letter to US AG Eric Holder, requesting an appeal of the case so that they can enforce capital punishment in their various states.

Missouri Adopts Propofol for Execution by Lethal Injection

As of May 15th, Missouri has adopted this protocol for execution by lethal injection using propofol. (Note the misspelling of the brand name Diprivan.) APP manufactures both Diprivan and generic propofol, Hospira only the generic. The American Society for Health-System Pharmacists reports that the drug is in short supply due to "manufacturing delays" at Hospira.

Given the new protocol, the Missouri Attorney General has petitioned the Missouri Supreme Court to set execution dates for the nine death row inmates who do not already have a date set. All prisoners and their attorneys were also informed, and legal challenges to the untested execution protocol are to be expected.

I tell the detailed story of lethal drugs for injection in my posts below, but here is a summary. Hospira was the only US-approved source of the sodium thiopental that was originally used for lethal injection, but the Italian manufacturing facility with which they contracted refused to produce the drug without guarantees that their output would not be used for executions. Hospira's company policy does not prevent the sale of their products for this purpose. Nebraska fraudulently obtained thiopental from the Indian manufacturer Naari under the guise of having drug samples shipped to Zambia for approval and registration in that country. Naari has requested that the Nebraska Supreme Court order the return of their product, to no avail. After thiopental became hard to obtain, pentobarbital began to be used. It is now unavailable from Lundbeck, the only US-approved supplier, due to the company's enforcement of a shipping procedure designed to prevent the sale of their product for executions. Texas obtained some of their product by deceit, using a DEA registration number for the long-shuttered Huntsville Prison Hospital, and refused to return it to the manufacturer. Texas Attorney General Greg Abbott recently upheld an open records request that revealed that the state has supplies for 23 executions because the Texas Department of Criminal Justice is not following its own protocol and mixing a backup dose. (See syringes 1A, 2A, 3A, and 4A in the Missouri protocol for an example of how backup doses are prepared.)

Shortage of injectable pentobarbital for execution by lethal injection

Shortage of injectable pancuronium

Shortages of Drugs for Lethal Injection

Shortage of injectable potassium chloride

Shortage of sodium thiopental for lethal injection

Nebraska's thiopental for lethal injection

Nebraska's thiopental for lethal injection

Nebraska has refused to turn over its stock of thiopental for lethal injection to the FDA. The FDA was following a court order issued by US District Judge Richard Leon. The source of Nebraska's thiopental is dubious at best. (My bold added to my earlier post.)

Purchases from India: In 2010 and 2011 various US states inquired about and some purchased thiopental from India.  The Sunday Guardian reports that Navneet Verma, managing director of Kayem Pharmaceuticals, bought vials of thiopental with English labels from Mumbai company Neon Laboratories for sale to Nebraska and South Dakota because his existing stock was labeled in Portuguese for use in Angola. The Times of India reports that Kayem consists of a Mumbai office and storeroom, with a kitchen on a balcony. This seems very similar to the questionable situation with Dream Pharma. Later in 2011, Mr. Verma reversed his decision to sell more thiopental to various US states that had sent him inquiries.

Another Indian company, Naari, was duped by an Indian purchaser, Chris Harris, who stated that he was buying samples to ship to Zambia for approval and importation to that country. Instead, the drugs were sent to Nebraska, and Naari has protested to the Chief Justice of the Nebraska Supreme Court and started legal proceedings for their return. The Indian Express reported other details of this story.

Nebraska Attorney General Jon Bruning has urged the FDA to appeal Judge Leon's decision, and further litigation is assured in order to determine the administrative discretion of the FDA and to delineate the roles that the FDA and DEA will play in issuing import licenses.

Shortage of sodium thiopental for lethal injection

The shortage of sodium thiopental for lethal injection continues, and the US response to the shortage has progressed beyond that in my previous post below. First, a reminder that there is no FDA-approved source of injectable sodium thiopental. Any sodium thiopental imported for health care is an illegal substance. In contrast, the FDA has not acted on importation of thiopental for lethal injection. Beaty et al. v FDA has challenged this inaction in federal court and yesterday US District Judge Richard Leon banned the import of thiopental for lethal injection and ordered the states to return any supplies obtained abroad. Reuters quotes from Judge Leon's written opinion:

"The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle. How utterly disappointing!"

Here is a PDF of the judge's order accompanying his opinion. The APA reference in the order is the Administrative Procedures Act. As I understand this law, one of its requirements is that federal agencies establish uniform standards governing their conduct. According to Judge Leon, the FDA has violated this requirement by refusing to act in the case of thiopental for lethal injection, as opposed to all the many actions the FDA does take to ensure that only safe and effective drugs are approved for import.


Shortages of Drugs for Lethal Injection

Shortage of injectable potassium chloride

The American Society of Health-System Pharmacists reports a shortage of injectable potassium chloride. This drug shortage is important to people whose potassium levels are too low (hypokalemia) and who can't take it by mouth for some reason. Potassium chloride injection is an antidote to digitalis poisoning. When a physician prescribes digoxin to improve the heart's efficiency, potassium levels are usually monitored because hypokalemia can lead to cardiac arrest.  Potassium chloride is injected directly into the heart muscle in order to stop the heart for some surgeries.

In Texas potassium chloride is the third drug injected during an execution. Now all three drugs used for execution for lethal injection are in short supply.

Shortage of injectable pentobarbital for execution by lethal injection

Shortage of injectable pancuronium

Shortages of Drugs for Lethal Injection

Shortage of injectable pancuronium

The American Society of Health-System Pharmacists reports a shortage of pancuronium for injection. This drug shortage impacts surgery and intubation. In both procedures it is used to temporarily paralyze the skeletal muscles. This is an instance in which changing to one of the alternatives can cause confusion and errors because medical personnel may not be familiar with the different time of onset, duration of effect (see table), and the agent used to reverse the effects. For example, pancuronium's effects are routinely reversed with neostigmine, but if you use succinylcholine to paralyze the skeletal muscles, neostigmine increases the effect.

Injectable pancuronium is the second drug administered for lethal injection, and Hospira is now the only US-approved manufacturer. This further complicates the implementation of death warrants because of the shortage of injectable pentobarbital, the first drug administered for lethal injection. Links to my previous posts are given below.

Shortage of injectable pentobarbital for execution by lethal injection 

Shortage of injectable pentobarbital for execution by lethal injection - Update

Shortage of injectable pentobarbital for execution by lethal injection - Update 2

Reuters reports that yesterday the state of Virginia executed Jerry Terrell Jackson using pentobarbital. A spokesman for H. Lundbeck A/S of Denmark, Matt Flesch, in an interview with the BBC, said:

"We're in the business to improve people's lives, so the use of pentobarbital to end people's lives contradicts everything that we're in business to do."

Since the company has previously stated that it has never sold directly to prisons, the drug must have been diverted before the company reorganized their distribution system to prevent its use for lethal injection. Please read my prior posts for more information.

Shortage of injectable pentobarbital for execution by lethal injection - Update

On ScienceBlogs today, Isis the Scientist references the same press release from H. Lundbeck A/S as my previous post, with the following addition:

"This makes me wonder about the future of Nembutal [trade name for pentobarbital] in places with the death penalty.  Many US prisons have hospital facilities with in [sic] staff doctors and nursing staff.    Will prisoners in prisons in states that still have the death penalty continue to have access to Nembutal as a therapeutic option?  Or, has Lundbeck made plans to stop supply for these purposes out of fear that prisons will re-purpose the drug for executions?"

I also found the comments worthwhile. The comment by daedalus2u is especially interesting:

"The [sic; they] do say that they have never sold any to prisons...."

"If they [Lundbeck] put a clause requiring the purchaser to say they will not allow it to be diverted under penalty of perjury, that makes it a criminal offense to divert it. It is a Class II controlled substance, so diversion of it is already illegal. Lundbeck is perfectly within their rights to consider diversion for lethal injection an unapproved use just like injection to get high is an unauthorized use."

Once again, this comment is worth reading in its entirety.

Shortage of injectable pentobarbital for execution by lethal injection

H. Lundbeck A/S, a global pharmaceutical company located in Denmark, is the only US licensed provider of pentobarbital. Their press release makes clear the company's determination to do whatever necessary to avoid the use of their drug for execution by lethal injection. Currently they have reorganized their distribution system with the intent of supplying the drug for therapeutic purposes only, and will continue to evaluate how their drug is being used. The drug has a two year expiration date, making present prison supplies unavailable for executions after 2013. The state of Texas has enough for the eight executions scheduled, but will not comment on supplies available after Lawrence Russell Brewer's execution September 21st.