SSA notes: The Lancet Commission and the North American opioid crisis

Stanford University and The Lancet teamed up to summarise the causes of, and solutions to, the North American opioid crisis. The SSA website team picks out the bits you need to know, and discusses the relevance for UK settings.

The first thing to note is that, although this report details the history of the opioid crisis, it is not a report about the past. The North American opioid crisis is happening now and continues to happen. The worst year for opioid overdoses in the USA and Canada was in 2020. As the recommendations from this report are considered and implemented, overdose rates will continue at record levels, as will all the other attendant harms.

Most of you will be aware of the North American opioid crisis. The trouble is that the crisis has so many moving parts that it can become difficult to maintain focus. One week it is about prescriptions, the next it’s about fentanyl and dual drug use. This report brings it all together, presenting an authoritative ‘take’ on the causes of and solutions to this major public health problem, whilst acknowledging where there are no simple answers. It is the kind of quality you would expect from Stanford University, The Lancet, and the impressive list of authors.

The Lancet Commissions provide recommendations that have influenced health policy and practice on the most pressing issues in science, medicine, and global health. This particular commission on the North American opioid crisis was “formed in response to soaring opioid-related morbidity and mortality in the USA and Canada over the past 25 years”, and was led by Keith Humphreys, Professor of Psychiatry and Behavioral Sciences at Stanford University and Deputy Editor-in-Chief at Addiction.

Some of the final words of this document capture its tone and ambitions:

The authors say, “It took more than a generation of mistakes to create the North American opioid crisis. It might take a generation of wiser policies to resolve it.” These ‘wiser policies’ followed 7 themes:

1. Recognising the North American opioid crisis as an example of ‘multi-system regulatory failure’
2. Recognising the dual nature of opioids (i.e. their benefit and their risk to health)
3. Building integrated, well-supported, and enduring systems of care for people with substance use disorders
4. Maximising the benefits (and minimising the adverse effects) of the criminal justice system
5. Creating healthy environments that can bring about long-term reductions in the incidence of substance use problems
6. Increasing innovation in response to the opioid crisis
7. Preventing the North American opioid crisis from spreading globally

Several of these reflect recommendations in the recent UK Drug Strategy, such as improving treatment and increasing commitments to prevention and research. Several are very specific to the North American opioid crisis. It’s the latter that we explore below.

‘Multi-system regulatory failure’

The first section of the report is on what caused the US opioid crisis. In the field of addiction, there are many subjects that make for sober reading; yet this part of the report still manages to shock. The authors outline the three waves of the opioid crisis (see below) with a detailed account of how the crisis unfolded. They go on to describe failures of regulation and the enormous scale of ‘Big Pharma’ corruption. It is a very depressing read.

The report concludes that the initial wave of the opioid crisis was a result of weak laws and regulations combined with high incentives for pharmaceutical companies. For example, OxyContin was approved by the US Food and Drug Administration, based on a “fraudulent description of the drug as less addictive than other prescription opioids”.

The report describes inappropriately close relationships between opioid manufacturers and lawmakers, patient advocacy groups, professional societies and universities. It collects stories of “aggressive product promotion to prescribers” whereby physicians were given incentives for prescribing opioids and for increasing opioid prescriptions.

Then there’s the ‘revolving door’, where people working as government regulators will suddenly move to work for the pharmaceutical companies they once regulated. The report questions the willingness of those people to hold companies to account, when those companies are likely to be their future (and very well-paying) employers. The huge scale of pharmaceutical influence is only matched here by the dearth of tools available for regulators.

Moving towards solutions, the Commission recommends restricting pharmaceutical product promotion, insulating medical education from pharmaceutical industry influence, closing that ‘revolving door’, making post-approval drug monitoring and risk mitigation a function of government, and ‘firewalling’ bodies that have formal power over prescribing from industry influence. The Commission also recommends exposing advocacy groups that are funded by industry and restoring limits on corporate donations to political campaigns – all of this to try and lessen the “overwhelming political clout of the [pharmceutical] industry”.

The dual nature of opioids

Opioids are at the centre of this problem, of course, but it is important to hold in mind that they can be essential for pain management; they are bad for some things and good for others. From a regulatory perspective this is tricky. The Commission recommended that regulators hold this dual nature in mind “rather than adopting either overly lax or overly restrictive prescribing policies, both of which have substantial potential for harm”.

Improving pain management is crucial, and could be facilitated in the US through the 2016 National Pain Strategy. Other ways to build responsible opioid prescribing practices include prescription drug monitoring programmes, prompts in electronic prescribing systems that nudge clinicians towards safer prescribing, and expanded access to opioid agonist therapy (e.g. methadone). Pharmaceutical companies, however, once used those same systems to nudge physicians towards increasing opioid prescriptions. There is a dual nature to ‘nudge tactics’ too.

Opioid dependence arising from prescribed opioids is not as prevalent in the UK as in the US, yet opioid prescribing more than doubled in the UK between 1998 and 2018. An analysis of UK data by the Faculty of Pain Medicine indicated that, while the number of patients using prescription opioids alongside illicit drugs has remained relatively stable, the proportion of individuals who use prescription opioids as their sole drug has increased. It is the latter group that has increasingly sought help from treatment services.

Systems of care for people who use drugs

Here, we are on familiar territory. The Commission recommends better treatment, including criminal justice interventions and prevention. More research and innovation – all fairly similar to the Dame Carol Black recommendations in the UK. As with the UK Drug Strategy, the report authors talk about better collaboration between services and improving activities for children and young people. They give the Iceland model as an example (read information about the SSA-funded Youth in Iceland Model (YiIM) project here, here and here).

In a moment of historical resonance, the report encourages people working in the field of addiction to set aside long-running disputes between factions (harm reduction, recovery, abstinence – you get the picture) and work towards a unified ‘public health’ approach – a recommendation as important as it is optimistic.

The Commission, like Dame Carol Black in the UK, also recommends a major investment in workforce development – specifically increasing the number of substance use specialists and increasing the addiction-related knowledge and skills of general practitioners (GPs).

Preventing a global opioid crisis

After 20 years, the opioid crisis is at a peak in North America. But it is only just starting in other countries, many of which have less capacity than the US to regulate or resist pharmaceutical industry influence. The Commission warns that pharmaceutical companies based in the US are already and actively expanding opioid-prescribing worldwide “using fraudulent and corrupting tactics that have now been banned domestically”.

The report urges US regulators to stop pharmaceutical producers from exporting aggressive opioid-promotion practices abroad, and recommends that the World Health Organization and donor nations coordinate provision of free generic morphine for analgesia to hospitals and hospices in low-income nations. International collaboration is far more difficult than selling opioids, but is an absolute priority if the North American crisis is to avoid becoming a global one.

Lessons for regulators

Overall, this report narrates the North American opioid crisis with unflinching detail. It lays the causes for the initial crisis squarely at the feet of pharmaceutical companies and the US government’s failure to regulate them.

The report is a warning about the importance of regulation in addiction policy. This is not the illicit drug market; prescription opioids are legal drugs that are provided by medical professionals, yet the lack of effective oversight has allowed a crisis of unprecedented proportions to grow unchecked. As well as addressing the global situation with opioids, governments must ask whether their responses to emerging regulatory issues around gambling and cannabis, for example, are adequate.

Drug policies often focus on restricting access to drugs; by the reckoning of this report, policies should place an equal emphasis on restricting industry access to policymakers, regulators, lawmakers and medical doctors.

The report frequently refers to the HIV/AIDS crisis, which was perhaps the last big catalyst for change in addiction treatment, ushering in needle exchange and other harm reduction services in the UK. The global opioid crisis has the potential to provoke similar changes in regulation, prevention and treatment in the US and across the globe. The potential for policymakers to make these changes leaves some room for optimism at the end of what is a bleak, but very important report.

by Rob Calder and Natalie Davies

---

The opinions expressed in this post reflect the views of the author(s) and do not necessarily represent the opinions or official positions of the SSA.

The SSA does not endorse or guarantee the accuracy of the information in external sources or links and accepts no responsibility or liability for any consequences arising from the use of such information.

---