Monday, June 13, 2011

First Do No Harm - When Live Saving Becomes Life Taking: Execution Medicine

Wednesday, January 26, 2011, AP Legal Affairs Writer Andrew Welsh-Huggins released a story picked up by Yahoo News which made public a drug company’s regret that one of their products has been selected as part of a cocktail to end the life of death-row inmates in Oklahoma and as the only product in Ohio. The manufacturer has no control over who their end users will be and therefore cannot control its use for a harmful purpose. (para.7) This article raises a very volatile ethical and philosophical question: What should be the response and action of a medicine manufacturer when the very drug created to help the living is used instead to create death? This situation not only violates the Hippocratic Oath, but also the position of the Catholic Church on the dignity of life. With an ongoing national conversation of the unintended harmful consequences of medicines, treatments and even vaccinations2, a medical company dealing with the use of their product to purposefully inflict harm must be dealt with.

The drug in question is Pentobarbitol by Lundbeck, Inc. Pentobarbitol (trade name Nembutol) is already in use by Oklahoma Department of Corrections to cause unconsciousness in combination with Vecuronium Bromide which stops respirations and Potassium Chloride which stops the heart. (2008, Oklahoma Correction) Both institutions previously used Pentothal (sodium thiopental) manufactured by Hospira, but has had to make a change as Hospira has chosen to cease production due to its use by correctional facilities on death row inmates. (2011, Hospira News Release)

According to their website, Lundbeck, Inc. has an official tagline of: “One Purpose. One Promise. Fulfilling unmet medical needs. Improving Lives.” Their medicines treat rare and devastating diseases such as Huntington’s, treatment resistant complex partial seizures and others. Pentobarbitol’s specific use as outlined in the prescribing information is:
NEMBUTAL® (pentobarbital sodium injection, USP) is indicated for use as a sedative, a hypnotic for short-term treatment of insomnia, preanaesthetic and as an anticonvulsant in the emergency control of certain acute convulsive episodes, such as those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus and toxic reactions to strychnine or local anesthetics. (Lundbeck 2010) Also, according to the prescribing information in the Physician’s Desk Reference of 2007, the official indications for sodium pentobarbital (trade name of Nembutal) are “as a sedative, … a hypnotic for the short-term treatment of insomnia … Preanesthetics … and [emergency] anticonvulsants…” (p 2470)

Lundbeck wrote letters to both Oklahoma and Ohio expressing its displeasure at the practice, but the letters are private and Lundbeck’s actual language is not known. At the date of publication of the article, both states denied having yet seen the correspondence. (Welsh-Huggins para.5) Interestingly, no notice of the topic can be found on Lundbeck’s official website; even in the press release section.

The moral situation in which Lundbeck finds itself is this: does it cease to manufacture the medicine specifically to prevent its use? Or, does it denounce the practice of using it to take lives and continue to provide it to those who are in need of it? The official statements by Lundbeck as expressed in Welsh-Huggin’s article seem to give their current answer to this question.

"This goes against everything we’re in business to do. (para.3) …
We like to develop and make available therapies that improve people’s lives. That’s the focus of our business. (para.4) …
While we cannot control how our products are administered, it is our intent that our products be used in a safe and appropriate manner and encourage use consistent with the label. (para.8)"So for now, Lundbeck will continue to produce Pentobarbital while publicly opposing its use for executions in Oklahoma and Ohio.

It appears that Lundbeck became involved because of a different decision made by Hospira. A January 31, 2011 article by Reginald Fields of Cleveland.com stated that “Ohio finds itself in this position [of changing medicine and manufacturers] after Hospira Inc., of Lake Forest, Ill., the country’s only maker of sodium pentobarbital, announced it would no longer make the drug in protest over it being used for lethal injections.” (para.26) This obviously states that Hospira made its decision based on the moral crisis in which it found itself.

In the Welsh-Huggins 2011 article, the paragraph addressing Hospira read “That drug’s [sodium pentobarbital] sole U.S. manufacturer … deplored the drug’s use in executions and also asked states not to use it, to no avail. The company announced last week it was discontinuing the product.” (para.11) While not stated outright, one could assume that Hospira was ceasing production in protest. However, a CBS news article of only a month prior reported Hospira with a different situation than a moral one. “But Hospira Inc. … said Thursday new batches of the drug could be available ‘in the first quarter’ of next year. They blamed the shortage on problems with its raw material providers.” (Freeman, para.4)

So which is it; moral or business? It can easily be both. Hospira can both deplore the use of their medicine for a purpose so deviant to the call of medicine and choose to continue production for those who need it. It finally appears in Hospira’s official statement that the latter is the case. Eventually, it was a legal threat that caused them to close their doors on sodium pentobarbital.

Hospira had intended to produce Pentothal at its Italian plant. In the last month, we've had ongoing dialogue with the Italian authorities concerning the use of Pentothal in capital punishment procedures in the United States – a use Hospira has never condoned. Italy's intent is that we control the product all the way to the ultimate end user to prevent use in capital punishment. These discussions and internal deliberation, as well as conversations with wholesalers - the primary distributors of the product to customers - led us to believe we could not prevent the drug from being diverted to departments of corrections for use in capital punishment procedures.

"Based on this understanding, we cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment. Exposing our employees or facilities to liability is not a risk we are prepared to take. Given the issues surrounding the product, including the government's requirements and challenges bringing the drug back to market, Hospira has decided to exit the market. We regret that issues outside of our control forced Hospira's decision to exit the market, and that our many hospital customers who use the drug for its well-established medical benefits will not be able to obtain the product from Hospira."
(Hospira, January 2011)
So, it appears that Hospira would have preferred to continue to provide its product to those who needed it in a medically necessary use, but legal situations backed them into a corner. Since they could not control the use of others and were not willing to risk their business or their employees’ livelihoods, production ceased.

The only remedy available to this dilemma is this: to eliminate the death penalty. It has long been known that lethal injection is the most humane way of putting a prisoner to death which puts every drug manufacturer in the potentiality of this moral crisis. (Brauchli, para.2) Drugs in state executions are also sed in the euthanasia of pets during their suffering. (Brauchli, para.7) But, death row inmates aren’t suffering pets. They are humans. They are people. They are individuals and while their crimes may have been heinous, removing their lives does not undo their action. Removing their lives is not always necessary. If the laws were such that lethal injection or any capital punishment were used only in provable extremes where life in prison could not protect the public from the offender, or the offender from himself, it would be in keeping with Catholic Social Teaching (Zalot, Guerin, pp141)

What is obvious is that neither company desired or condoned the use of what they had created for such a purpose. However, what may also be gleaned is that they counted the lives they saved as important. They could not stop legal authorities from using their medicines as instruments of death, but they could still promote them as instruments of life to many of the suffering while speaking out to decry the use by states for lethal injection.



1. “First Do No Harm” is a slight mistranslation in the “common knowledge” of western culture as the “Hippocratic Oath.” However, the original from the “Hippocratic Corpus” does explicitly state, “The physician … must mediate these things, and have two special objects in view with regard to disease, namely, to do good or to do no harm.”
2. As the mother of a child on the autism spectrum with multiple co-morbid conditions including autoimmune, this “national conversation” is of great personal interest. The use of a medicine purposefully causing death seems unconscionable.
References
Adams, Francis (transl.) The Internet classics archive. Hippocrates: Of the epidemics, Book 1, Section II, 5. , retrieved February 4, 2010 from "http://classics.mit.edu/Hippocrates/epidemics.1.i.html".
Brauchli, Christopher R., October 27, 2005, Humane Execution, originally published on humanraceandothersports.com, retrieved on February 4, 2011 from http://www.polisource.com/editorials/brauchli-2005-10-27-num150.shtml
Fields, Reginald, January 31, 2011. Ohio sticking with new drug for executions despite manufacturer’s
request not to use it., www.Cleveland.com, retrieved February 1, 2011 from
http://blog.cleveland.com/open_impact/print.html?entry=/2011/01/ohio_sticking_with_new_drugs_fo.html
Freeman, David W (December 17, 2010), Pentobarbital, Euthanasia Drug, Used in Oklahoma Execution: Was It Inhumane?, retrieved on February 1, 2011 from http://www.cbsnews.com/8301-504763_162-20025977-1031704.html
LaGow, Bette (Eds.) (2007). Physicians Desk Reference 2007 (61st ed.). Mondvale, NJ: Thomson PDR
Lundbeck (2010) Nembutal CII Sodium Solution retrieved February 1, 2011 from http://www.lundbeckinc.com/usa/products/cns/nembutal/default.asp
Office of Communications (January 26, 2011) Ohio Changes Lethal Injection Drug, Ohio Department
of Rehabiitation and correction: News Release, retrieved February 1, 2011 from http://www.drc.ohio.gov/Public/press/press393.htm
Oklahoma Department of Corrections (July 2008), Death Row, retrieved on February 1, 2011 from http://www.doc.state.ok.us/offenders/deathrow.htm


First Do No Harm - 7
Welsh-Huggins, Andrew, (Jan 26, 2011), APNewsBreak: Sedative maker deplores execution use, Yahoo
News, retrieved January 27, 2011 from http://news.yahoo.com/s/ap/20110126/ap_on_re_us/us_execution_drug_shortage
January 21, 2011, News Release: Hospira Statement Regarding Pentothal (Sodium thiopental) Market
Exit, News & Media/Press Relations, retrieved on February 1, 2011 from
http://phx.corporate- ir.net/phoenix.zhtml?c=175550&p=irol-newsArticle&ID=1518610&highlight=
Zalot, Josef D., Buevin, Benedict, OSB, (2008) Catholic Ethics in Today’s World, Anselm Academic

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