by Ravi B. Parikh, MD, MPP and Joanne Lynn, MD, MA, MS
On June 9th, 2016, California became the latest state to allow physician-assisted suicide. For all of the recent debate over legalizing physician-assisted suicide, one point often fails to be mentioned: Americans who choose to take lethal drugs will be unable to afford it. In February, Canada-based Valeant Pharmaceuticals purchased rights to secobarbital, the medication most used for prescription aid in dying (PAD; more commonly known as physician-assisted suicide) in the United States. Shortly after, Valeant doubled the price of secobarbital to $3,000 per lethal dose.
Lack of effective alternatives and inconsistent insurance coverage contributed to secobarbital's price increase, just as they do for other generic medications. However, three unique factors complicate any response to high prices of drugs used in PAD: the public divide over its acceptability, existing socioeconomic disparities in its use, and the historical ties to drugs used in the death penalty. Unless policymakers address these factors, individuals hoping to access legal prescription aid in dying may be unable to do so.
Authorization, use, and support of PAD are increasing. PAD is currently authorized by statute or court opinion in five U.S. states: Oregon (since 1994), Washington (2008), Montana (2009), Vermont (2013), and, most recently, California (2015). Most of these states authorize PAD for adults who submit a series of oral and written requests and who are certified by physicians to be mentally capable and have a terminal illness with estimated prognosis of six months or less. In Oregon, PAD is increasing in frequency as more people become aware of the practice and more physicians are willing to participate. Between 2011 and 2015, the number of prescriptions (114 to 218) and deaths from PAD (71 to 132) nearly doubled.
In the U.S., PAD requires patients to self-administer lethal drugs orally. Before 2015 in Oregon and Washington, most PAD cases used secobarbital (54 percent in Oregon; 64 percent in Washington) or pentobarbital (45 percent and 36 percent, respectively). Years of experience helped determine optimal doses of these drugs for PAD and other uses. Secobarbital's original patent was in 1934 to treat sleep disorders, and it is currently only available in an oral form. Pentobarbital has been used for many years as an anti-seizure medication. However, pentobarbital also has an intravenous form; in this form, it has been the drug most used for death penalty executions in the U.S. and physician-administered voluntary euthanasia in Europe.
This association with the death penalty has had important implications for access to PAD. In 2011, the Danish manufacturer of pentobarbital, Lundbeck, stopped manufacturing pentobarbital in the United States over concerns that it was used in lethal executions for prisoners, which is illegal and condemned in much of Europe. The subsequent drug shortage caused the price per lethal dose to rise from $500 in 2012 to over $15,000. As a result, pentobarbital essentially stopped being used for PAD in Oregon in 2015, with over 80 percent of PAD patients relying on secobarbital. An alternative three-drug cocktail of a long-acting barbiturate, a hypnotic, and an opioid -- reported to cost approximately $400 per lethal dose -- began to be used in 2015 in Oregon and accounted for 20 percent of PAD cases that year. However, only a few willing specialized compounding pharmacies can supply this cocktail. Furthermore, the effectiveness and safety of this new cocktail are less well established.
No drugs have been approved safe and effective in PAD. This is in part because of a 1985 Supreme Court opinion in Heckler v Chaney, stipulating that the Food and Drug Administration is not required to regulate drugs used for lethal injection or PAD. As more medications or formulations enter the field, states could require evidence of safety and efficacy by mandating the reporting of doses, adverse effects before death, and time to death. However, no states yet require this, and layperson witnesses to the death might find reporting these measures to be difficult.
Public sensitivities regarding PAD also yield uneven and sometimes uncertain insurance coverage of PAD drugs. The Assisted Suicide Funding Restriction Act of 1997 prohibited federal program coverage -- including Medicare, the federal component of Medicaid, and the Veterans' Health Administration. Insurance coverage has thus been left to individual state Medicaid or commercial plans. A recent bill in California proposes to mandate Medicaid coverage for drugs used in PAD, but state Medicaid and commercial insurance coverage remains unpredictable.
Insurance coverage for PAD would protect patients from costs by distributing risk to a large population, but it would not reduce the costs of lethal medications. To actually reduce the cost will require developing PAD drugs that are reliably effective and inexpensive. Perhaps the three-drug cocktail will accomplish this, as experience, use, and availability grows. However, this could take years -- over which time many more states are expected to legalize PAD. Furthermore, a serious initiative to control the price of PAD drugs could be more difficult than similar efforts to cut costs of other drugs, since such a negotiation will reopen the fractious debate on PAD itself.
Further escalation in PAD drug costs may exacerbate existing disparities in its use. In Oregon, of those who died via PAD, 71 percent had some college education or more, compared to 58 percent of the national population. These deaths were also more likely to be older white males dying from cancer. Fears of institutionalization or impoverishment could drive resource-poor individuals to want to accelerate the timing of death. However, inconsistent insurance coverage and higher prescription costs may make PAD unaffordable for poor people. Ironically, high costs for lethal medications might balance the effects of coercive financial situations, though long-term care costs still overwhelm the costs of PAD drugs.
Research to develop other PAD drugs that can only be ingested orally might engender competition and bring down prices. Currently, the number of individuals utilizing PAD is far too low to incentivize new drug alternatives. However, public support for PAD could spur demand to develop alternatives. Importantly, none of this would affect the price and availability challenges affecting death penalty cases, since those require injectable drugs.
Making secobarbital a focus of drug company profits is unsettling, even for those who have opposed legalization of PAD (including one of us). One would reasonably want people to live well as long as they can and to have little cause for seeking an earlier death. But in states where PAD is authorized, one would also reasonably want people to make choices about treatment and survival without being pressured by the high costs of PAD or of long-term assistance. This debate is vigorous enough when considering ethics and emotions. Drug pricing should not play a role in it.
Dr. Parikh is a resident physician at Brigham and Women's Hospital. Dr. Lynn is Director of the Center for Elder Care and Advanced Illness at the Altarum Institute.