A storm is brewing with the potential to create a global “public health crisis”, denying access to safe surgery and anesthesia for roughly a billion people in low-income countries. The issue at stake? Access to ketamine, the anesthetic of necessity in most low-income countries.
The Commission on Narcotic Drugs, the central drug policy-making body within the United Nations, has been asked to review a proposal to place ketamine in Schedule I under the Convention on Psychotropic Substances of 1971 (E/CN.7/2015/7). This move is being passed off as being as major victory for reducing illicit use, while the medical impacts are being underplayed: other countries (mainly high income countries) have placed ketamine under national control, and there have been no documented national public health crises in these countries. However, the reality for low-income countries is far from it, and there is little reason to suspect that ketamine, if placed under controls, is likely to be saved from a similar fate as other controlled medicines of poor access, restricted use, and being implicated in the unnecessary suffering of millions of people.
First, the proposal. China has requested that ketamine be placed in Schedule I of the Convention on Psychotropic Substances. Under the Convention, drugs in Schedule I are prohibited from being used except for “very limited medical purposes.” This is clearly an inappropriate characterization of a drug that is considered to be an essential medicine for both adults and children by the World Health Organization, and is widely used in low-income countries as a cheap, safe, and effective anesthetic and analgesic. Furthermore, esketamine (a slightly different version of ketamine), has shown promise for treatment-resistant depression with Johnson & Johnson currently running a phase 2 clinical trial of an intranasal version of the drug. In short, characterizing the drug as having very limited purposes is clearly inappropriate and inaccurate. Furthermore, placing it in the company of other Schedule I substances – LSD and PCP, for example – is outrageous.
Second, this places the Commission on Narcotic Drugs in yet another awkward position. To place a drug under international controls requires a review and recommendation by the World Health Organization through the Expert Committee on Drugs and Dependence (ECDD). The ECDD reviewed ketamine in 2014 (and previously in 2006) and both times has recommended against placing the drug under international controls. The reasons for this recommendation? First, there is limited evidence of harm associated with ketamine abuse, aside from lower urinary tract problems. Ketamine is a powerful dissociative drug, so clearly acute intoxication with the drug will produce psychological effects, but the long-term harms of use seem to be relatively confined to a subgroup of the population and not widespread. The drug is used and abused recreationally, and that is something that everyone – including the medical community and the ECDD – acknowledge and want to prevent; however, the ECDD clearly note that abuse and diversion of the drug are not so widespread as to constitute a public health crisis. That is to say, the risks of scheduling ketamine far outweigh its benefits.
This is far from a cautionary tale of drug policy gone astray; this is a recognition of the fact that that the international drug control system has likely created, and has certainly exacerbated, the greatest global health inequity in the world: an inability of people in pain to access analgesics that are both effective and affordable. And this is a problem that overwhelmingly affects the poor. Check out a graph from a manuscript my colleague and I published a few years ago in PLOS Medicine of the morphine that is theoretically available on a per capita basis around the world (I say theoretically, because this represents import quotas – the maximum allowable amount of morphine to be imported in each country per year – rather than actual consumption, which is likely much lower):
The differences are immediately noticeable, with not one low-income country being in the same ballpark as any of the high-income countries. We have known for years that access to analgesics is virtually non-existent for 80% of the world. Yet, the Commission on Narcotic Drugs is prepared to make the same mistakes over again.
The global health community needs to wake up to this inequity that is an offensive and flagrant violation of human rights. The World Federation of Societies of Anesthesiologists (among other anesthesia organizations) has spoken out against this, but others must take action as well, particularly in low-income countries that will undoubtedly be disproportionately affected by this move. Ketamine will be discussed at the CND meeting in Vienna sometime on March 13th, so the time to act is now.
Check out this background fact sheet on ketamine for more information.