U.S.: Dealing with medicines misuse in execution by lethal injection

It is time to debunk the myth that lethal injection is a humane procedure, and remove medicines from the capital punishment process, says Maya Foa, director of Reprieve, an international organisation that defends the human rights of people vulnerable to the world's most powerful governments.

The Hague has been the location of many significant international events. A small office in the Dutch Ministry of Foreign Affairs just welcomed a new milestone. This time it was not a new treaty or convention, or a new precedent in international criminal law, but a big step in the pharmaceutical sector's efforts to stop the misuse of medicines for lethal injections.

On 27 September 2017, the Organisation for Economic Cooperation and Development (OECD) in the Netherlands published its assessment of pharmaceutical giant Mylan's work to stop prisons using its drugs in executions[1]. New standards of industry best practice have been established for implementing distribution controls on drugs that could be used for execution.

The OECD's dialogue with Mylan started in March 2015 after the prominent Dutch human rights lawyer Bart Stapert raised concerns that the company, headquartered in the Netherlands, was not implementing the same strict controls on the sale and distribution of its medicines as its competitors. Mylan manufactures the anaesthetics midazolam and etomidate, and the paralytics rocuronium bromide and vecuronium bromide, which have all been sought for use in capital punishment in the United States (US).

This unique process brings together a wide range of interested parties. The discussions, facilitated by the organisation's local office in The Hague, involved not only Mylan and Mr Stapert, but also the pharmaceutical company's major investors and expert stakeholders.

Things moved quickly. 6 months after the process began, in September 2015, Mylan released a statement making clear for the 1st time that it did not approve or authorise the use of its products for use in lethal injections[2]. Mylan also said it would change its contracts to legally restrict distributors from selling its medicines to executing states.

But controls on the distribution of medicines are effective only if they are implemented properly, especially while US states look for new drugs as current stocks run out.

Recommendations for pharmaceutical companies

State officials will go to great lengths to hide the source of their lethal injection, so constant vigilance and a proactive approach is necessary. In its evaluation of Mylan's distribution controls, the OECD recommended steps for all pharmaceutical companies to follow[1].

Companies should adopt a 'clear and unequivocal position' against secrecy laws used by US states to hide the source of their execution drugs

First, companies should be proactive in adding drugs to restricted lists while new lethal injection protocols emerge. 2nd, compliance should be monitored through the supply chain using sales data with after-sales checks on a monthly or bimonthly basis. 3rd, companies should adopt a "clear and unequivocal position" against secrecy laws used by US states to hide the source of their execution drugs. And 4th, manufacturers should contact officials in executing states to inform them of their position.

The pharmaceutical industry is global; most manufacturers and distributors operate across borders. The development of an international set of guidelines on this issue is a significant step that will benefit manufacturers and consumers around the world. The OECD work adds to other efforts by individual companies to ensure that their life-saving medicines are not misused by executing states.

Restriction of sales

Since 2011 - when the global drug maker Lundbeck became the first company to comprehensively restrict the sale of its medicines to death row - more than 30 pharmaceutical manufacturers and distributors have introduced supply chain controls to stop their drugs being misused in lethal injection executions. Every major manufacturer and supplier of drugs that US states have used in executions has publicly stated their opposition.

Executing regions in the US began to have problems getting hold of the drugs to be used for executions in 2010 when Hospira stopped producing the barbiturate sodium thiopental, used widely as part of the lethal injection process. As Departments of Corrections across the US searched for alternative supplies, they found a British 1-man operation - Dream Pharma - based in an office at a driving school in a west London suburb.

When the British government introduced export controls and shut off this route, states sought supplies of sodium thiopental from India with the help of a notorious middleman man, Chris Harris, who has no pharmaceutical background. The Swiss company Naari - which manufactured sodium thiopental in India - became aware that Nebraska had got hold of their drugs in 2012, and demanded them back, noting that Harris was supposed to send them to Africa for medical use but had instead diverted them to the US.

States switched to other drugs including pentobarbital, manufactured by Lundbeck, but opposition across the industry was growing and the decision by the multinational pharmaceutical company to restrict sales was just the start of the opposition to the misuse of medicines in capital punishment.

By 2013, state officials started to look for alternative drug supplies and settled on a range of new 2-or-3-drug cocktails, usually starting with the sedative midazolam.

Botched executions

Over the following years, every state that used midazolam had what appeared to be at least 1 botched execution. Inmates were not fully unconscious and were therefore exposed to pain and suffering. Perhaps the most extreme example of this was the execution of Clayton Lockett in Oklahoma in 2014.

It took 43 minutes for Lockett to die and he was described as having groaned, writhed and shouted out. There were multiple puncture wounds over his body caused by the executioners' desperate attempts to insert more IV lines to give him a higher dose of lethal drugs. We may never know the true extent of his suffering because the curtain between the execution chamber and the witnesses was closed as soon as it became obvious things were going badly wrong. This is typical of the secrecy that shrouds the execution process in the US.

State legislatures across the US have introduced laws to hide the ways they purchase their lethal injection drugs

As state legislatures across the US have introduced laws to hide the ways they purchase their lethal injection drugs, industry efforts have extended beyond just restricting sales.

Earlier in 2017, the major American pharmaceutical wholesaler McKesson launched unprecedented legal action in the state of Arkansas, demanding the return of a batch of the paralytic vecuronium bromide, which the state had purchased for upcoming executions[3]. The company states that the Arkansas Department of Correction "intentionally sought to circumvent McKesson's policies to procure Pfizer's vecuronium bromide under the auspices that it would be used for medical purposes". The case is ongoing in the Arkansas courts.

This concerted action reflects unanimous opposition across the pharmaceutical industry to the use of medicines by prison officials in capital punishment procedures - an application for which they were never designed, and which runs fundamentally counter to their life-saving purpose.

Companies know that if their products are misused in executions, they face costly litigation

It is no secret that there is a commercial imperative behind the companies' opposition: after all, they know that if their products are misused in executions, they face costly litigation, negative media coverage and divestment by major shareholders.

The pharmaceutical industry makes medicines to save and improve patients' lives, so, primarily, the use of these products to end lives is fundamentally counter to the industry's objectives.

New combinations of drugs

In recent weeks, Florida has executed people with a combination of drugs that has not been used before, replacing midazolam with etomidate. The global pharmaceutical giant Johnson & Johnson was quick to condemn the use of a medicine it had developed.

On 14 November 2017, Nevada had planned to carry out its 1st execution in 11 years using an even more experimental cocktail that includes the opioid fentanyl, which has become famous around the world for the addiction crisis it has caused. However, the accused Scott Dozier made objections about the selection of drugs that would end his life. The county court issued a stay, and the case could lie in the hands of Nevada's supreme court.

I have worked with and consulted for almost every global pharmaceutical company that has been affected by lethal injection issues. Constructive collaboration and dialogue is the most effective way to achieve the ends we all seek: this is the lesson I take from the OECD process. Mylan's positive engagement, and that of its shareholders, in the establishment of these standards for industry best practice shows what is possible when we work together.

The number of executions taking place in the US has reduced over time, from a peak of 98 in 1999 to just 20 in 2016[4]. The decrease, in no small part, is due to the reasoned and authoritative opposition of the pharmaceutical industry to the misuse of their medicines in executions.

While officials continue to use underhand tactics to obtain drugs, the industry must continue its proactivity in challenging misuse. Executions are not legitimate medical procedures, yet the death penalty in the US has been partly sustained through a pervasive myth that lethal injection is a humane, medicalised procedure. It is time to debunk that myth and remove medicines from the process of capital punishment altogether.

References:
[1] Ministry of Foreign Affairs. National Contact Point. OECD Guidelines for Multinational Enterprises. Evalusation of the final statement of 11 April 2016: Bart, attorney vs. Mylan. Available at: https://www.oecdguidelines.nl/documents/publication/2017/09/27/evaluation-final-statement-stapert-vs-mylan (accessed January 2018)

[2] Mylan Newsroom. Mylan statement on its policy against the use of Mylan products in capital punishment. 30 September 2015. Available at: http://newsroom.mylan.com/press-releases?item=123361 (accessed January 2018)

[3] McKesson. McKesson response to Arkansas Department of Correction’s Planned Executions. 20 April 2017. Available at: http://www.mckesson.com/about-mckesson/newsroom/press-releases/2017/response-to-arkansas-doc-planned-executions/ (accessed January 2018)

[4] Death Penalty Information Center. Executions by year. Available at: https://deathpenaltyinfo.org/executions-year (accessed January 2018)

Source: The Pharmaceutical Journal, Opinion, Maya Foa, January 10, 2018

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"One is absolutely sickened, not by the crimes that the wicked have committed,
but by the punishments that the good have inflicted." -- Oscar Wilde