Perverse incentives: how the J&J verdict could harm palliative care patients

The USD 572 million verdict against Johnson and Johnson this week, resulting from a “public nuisance” suit brought by the state of Oklahoma charging the company with responsibility for the opioid crisis, raises concerns about how this and similar verdicts will harm the rights of patients to prescribed analgesics for legitimate medical use. Apparently the Sackler family, owners of Purdue Pharmaceuticals, are negotiating billion dollar settlements with various cities and states as this goes to press. While these enormous damage awards, which will bankrupt some companies, might help the cities recover public resources spent on epidemic, they will likely harm patients who need these essential analgesics for severe pain, leaving them without prescribers, pharmacists, or the necessary meds. This is already the case for patients in more than 75% of the world, who desperately need opioids for the control of severe pain! Will that number go north to 100% if pharmaceutical companies in the US simply stop producing essential opioids? These analgesics are on the WHO Model List of Essential Medicines for Palliative Care, and access is now widely considered a human right. A whole host of human rights violations could be the unintended consequence of these lawsuits!

To add insult to injury, it is unlikely that the civil suits and monetary awards, however well intentioned, will end the epidemic of non-medical use of opioids. People with dependence issues will simply go to the streets if they can’t get what they need at the pharmacy. The verdicts and settlements are an example of what one historian of the drug war calls imperfect coercion, which only exacerbate the underlying problem. Monetary awards resulting from civil verdicts or out of court settlements that bankrupt the legal industry create supply vacuums that provide incentives for drug cartels to hawk their very profitable lethal wares on the black and grey markets.

One reason that cities, towns and states are forced to prosecute the pharmaceutical companies under (civil) nuisance laws for widespread non-medical use of opioids among the population, is that the Federal Drug Enforcement Administration cannot charge the pharmaceutical companies with criminal conduct. The pharmaceutical companies are not technically cartels or “drug dealers.” They manufacture products approved by the Food and Drug Administration, another federal agency. These drugs are legal. They are only supposed to be dispensed and consumed for legitimate medical purposes by patients. The fact that this legitimate purpose spun out of control, and the products were used illegally (because the profits on improperly marketed opioids were simply too high for so many players to resist) is a governance failure that should be remedied through targeted policy solutions.

Moreover, because the FDA can criminally prosecute the pharmacies and physicians who prescribe and dispense the medicines, and describes them as “drug dealers,” many doctors who prescribe rationally, rather than criminally, will be deterred from entering or staying in what has not become a professional minefield. Even though the pharmaceutical companies can escape federal prosecution and incarceration, the physicians and their distributors take the fall and do the time. This makes doctors who do treat pain appropriately with opioids much more likely to think twice about ever prescribing them again, leaving patients with no relief at all.

The public health issue of the “US opioid crisis/overdose epidemic” represents a perfect storm of ideology, governance deficits, big money politics, and socio-economic deprivation, among other factors. Effective policies to dismantle the crisis without creating further harm will entail an equally multi-faceted, fine grained, political and ethical approach to policies around the regulation of controlled substances and internationally controlled essential medicines for the treatment of pain and palliative care.

If you can’t beat em, join em! Since DEA can’t bring criminal prosecutions against the pharmaceutical companies in federal court for failing to comply with their obligation to red flag the suspicious opioid orders that led to the epidemic, many DEA operatives are leaving the agency to work for the industry and consult on the opioid lawsuits! Alice Through the Looking Glass days!

A call to action. In order to prevent further harm to patients who need opioid medicines now, and those who will need them in the future, providers who use opioids as part of their legitimate practice will have to to work with the FDA, the DEA, and the judiciary, industry, as well as with the towns, states, and cities that will receive these cash awards, to ensure that sufficient product is manufactured and distributed to licensed professionals to meet legitimate medical needs. This sort of balanced policy has always been the goal of the international drug control system, but is one that has rarely been nurtured and supported by regional, national, and local law. Perhaps this crisis will provide an opportunity to devise a system that works for the benefit of all. May it be so.

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