An execution-frenzy may have been unleashed among death penalty U.S. States with execution drugs successfully sourced from India's Kayem Pharma Company. Will Indian authorities now tacitly condone the entry of generic drug manufacturers into a bloodthirsty niche of global commerce?

Brandon Rhode (31) was not in good shape when he was strapped into the execution chamber gurney on September 27 2010, in Georgia, United States. Six days earlier he had attempted suicide because, according to court documents, he did not want to be “put down like a dog.” As a result, he was left with “deep gaping wounds” from the razor he used to slash his neck and elbows. He was also said to have been brain-damaged from sheer blood loss.

Unfortunately for Rhode, convicted in 2000 of killing three persons during a burglary attempt, the worst was yet to come. For although medics spent 30 minutes trying to find a vein in Rhode's arm, into which they could insert needles to administer lethal drugs, something was clearly going wrong when the drugs started pumping. The first drug injected into Rhode, sodium thiopental, was supposed to render him unconscious, yet Rhode's eyes remained open throughout the procedure and moments before he was pronounced dead he was said to have turned his head and exposed the bandage over his slashed neck.

In a sworn declaration Mark Heath, a medical doctor and an expert witness in lethal injection cases, said: “Given the highly unusual provenance of the thiopental that was used in the Rhode execution, one explanation for the eyes remaining open is that the thiopental lacked efficiency.”

The “unusual provenance” that Dr. Heath mentioned in his report was a reference to the fact that the Georgia Department of Corrections (DOC) had imported the thiopental from Dream Pharma, a company located in the United Kingdom, “which operates out of the back of a driving school in London,” according to Dr. Heath.

Why did a key death penalty State of the U.S., itself a country steeped in a long and contentious history of capital punishment, have to resort to importing a lethal injection drug? A little bit of background is in order here, especially because since January execution drugs have entered the U.S. from yet another “unusual provenance” — Kayem Pharma Company of Mumbai, India.

While the history of the lethal injection goes back to May 1977, when the Oklahoma legislature first adopted it as a statute-supported method of execution, today 37 of the 38 death penalty States have lethal injection statutes. However, the entire execution “industry” in the U.S. relied on only one company for the supply of the lethal drugs cocktail — a firm called Hospira located in Lake Forest, Illinois. Emails, obtained by The Hindu, between Hospira and the Nebraska DOC, importer of thiopental from Kayem Pharma, made it clear that Hospira “do not support the use of any of our products in capital punishment procedures.”

Matters took a turn for the worse for States such as Nebraska when Hospira announced in the summer of 2010 that it had temporarily ceased production of thiopental due to a “shortage of raw materials.” Yet, according to Clive Stafford Smith, Director of a U.K.-based anti-death-penalty campaign group called Reprieve, the reason for the stoppage was that Hospira's plant was old and re-tooling it would be uneconomical given that thiopental is now off-patent.

Italy's stance

When Hospira sought to supply thiopental from a plant it owned in Italy, Reprieve campaigners worked with the Italian government, which was said to have been “shocked that Italy might be involved in the execution business,” and eventually “suggested to Hospira Italy that if they exported any drugs used for executions they might end up losing their export licence altogether.” At this point, according to Mr. Smith, Hospira made the “sensible decision” to cease production of the drugs altogether.

With the supplies of thiopental dwindling rapidly around the U.S., death penalty States saw themselves faced with two options. First, some of them, such as Ohio, Arizona, Oklahoma and Texas, switched to another anaesthetic, pentobarbital, commonly used for euthanising animals, and whose effects on human beings for execution purposes has never been tested.

States such as Ohio and Oklahoma have already executed four prisoners using pentobarbital, despite anaesthesia specialists such as David Waisel of Harvard Medical School warning that “the use of pentobarbital as an agent to induce anaesthesia has no clinical history... [and] puts the inmate at risk for serious undue pain and suffering.”

Act of desperation

In what might well have been an act of desperation, State executioners then decided to start importing thiopental, in the first instance from Dream Pharma in the U.K. Scarcely imagining the enormity of the legal backlash that would ensue, Arizona led the way, quickly executing Jeffrey Landrigan on October 25 2010 using the British thiopental. Georgia followed suit, executing Emmanuel Hammond on January 25 2011, having already executed Rhode.

The instant it was revealed in the British media that a home-grown company was supplying lethal drugs for U.S. executions, there was a flurry of public and legal campaigns mostly targeting two Liberal Democrats, Business Secretary Vince Cable and Foreign and Commonwealth Office Minister of State Jeremy Browne.

They initially declined to intervene; however they reversed that decision, reportedly after seeing evidence that the drug was only being exported for use on death row. Mr. Cable said: “In light of new information I have taken the decision to control the export of sodium thiopental. This move underlines this government's and my own personal moral opposition to the death penalty in all circumstances without impacting legitimate trade.”

The Kayem deal

Enter Nebraska DOC's transactions with Kayem Pharmaceuticals Private Limited, a small generic drug manufacturer based out of Marian Colony in Borivali, Mumbai. A series of emails, which The Hindu has in its possession, began between a representative of the Nebraska DOC and a Kayem sales representative in November 2010, the subject of discussion being the export of 500 one-gram vials of thiopental, valued at $2,056.15, from Mumbai to Nebraska.

The deal appeared to be progressing smoothly until the shipment reached Omaha around mid-December. A hold-up occurred at that point owing to the FDA's lack of clarity on whether or not the Nebraska DOC had a sufficient legal basis for importing the lethal drug. The FDA finally relented on January 7, 2011, making what informed observers described as a “political decision to not review the importation of the drugs.” It, however, clarified its position to the Nebraska DOC, saying: “In keeping with established practice, FDA does not review or approve products for the purpose of lethal injection. FDA has not reviewed the products in this shipment to determine their identity, safety, effectiveness, purity or any other characteristics.”

Yet with this action the FDA has risked unleashing an execution-frenzy among thiopental-starved death penalty States.

Already a likely victim of Indian-made thiopental has been identified — Carey Dean Moore (53). He awaits execution in the Nebraska DOC, now the owner of enough Kayem-manufactured thiopental to execute 166 men.

With the U.S.' patchy record of untested anaesthetics that fail to produce the expected unconsciousness, Moore may also expect the same outcome as Rhode, which Dr. Heath described thus: “There is no dispute that the asphyxiation caused by pancuronium [the second, paralytic agent administered] and the caustic burning sensation caused by potassium chloride [the third, heart-stopping agent administered] would be agonising in the absence of adequate anaesthesia.”

Unless last week's seizures of Kentucky's and Tennessee's stocks of imported thiopental by the U.S. Drug Enforcement Agency are repeated in other States and the proliferation of these untested drugs eventually stopped, we could enter a new era of “cruel and unusual punishment” for death row inmates across the country. Already, it is possible that the dubious Indian barbiturate has found its way into the broader healthcare system and reached the DOCs of several States.

India's options

And for India, itself a user of capital punishment, although in the “rarest of rare” cases, it is anybody's guess as to whether authorities will follow the stellar example of the U.K. and Italy and ban the export of lethal drugs to the U.S. Perhaps in a stroke of irony it will be economics rather than morality that will stall the entry of Indian generic drug manufacturers into this bloodthirsty niche of global commerce.

According to Reprieve's Mr. Smith, “Kayem can expect to be party to U.S. litigation for decades. It may have made them a small profit at the start, but they will end up paying lawyers until their profits have vanished one hundred times.”

Indeed, even as Reprieve held a press conference in Mumbai this week to raise awareness of the issue in the country, Kayem announced: “In view of the sensitivity involved with sale of our Thiopental Sodium to various... prisons in USA and as alleged to be used for the purpose of lethal injection, we voluntary declare that we... refrain ourselves in selling this drug where the purpose is purely for lethal injection and its misuse.”

However, if the lethal drugs export persists, even as India clamours for a more prominent place on the world stage, it will have to hide the embarrassing fact that it tacitly condones its merchants of death.

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